Trial Outcomes & Findings for Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT. (NCT NCT03990051)
NCT ID: NCT03990051
Last Updated: 2025-05-06
Results Overview
Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-05-06
Participant Flow
Double masked phase 10 weeks. Both Pro-ocular and Placebo groups received active treatment after 10 weeks for remainder of 2 years total from first dose..
Participant milestones
| Measure |
Pro-ocular™
Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
Pro-ocular™ group received active for 2 years beginning with first dose. The first 10 weeks were masks, whereas the remaining time was open-label active.
|
Placebo
Topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.
Placebo group was dosed with placebo topical gel for the first 10 weeks, followed by open-label active for the remainder of 2 years from first dosing.
|
|---|---|---|
|
Masked Period
STARTED
|
22
|
11
|
|
Masked Period
COMPLETED
|
21
|
11
|
|
Masked Period
NOT COMPLETED
|
1
|
0
|
|
Long Term Period
STARTED
|
21
|
11
|
|
Long Term Period
COMPLETED
|
13
|
8
|
|
Long Term Period
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Pro-ocular™
Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.
Pro-ocular™ group received active for 2 years beginning with first dose. The first 10 weeks were masks, whereas the remaining time was open-label active.
|
Placebo
Topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.
Placebo group was dosed with placebo topical gel for the first 10 weeks, followed by open-label active for the remainder of 2 years from first dosing.
|
|---|---|---|
|
Masked Period
Lost to Follow-up
|
1
|
0
|
|
Long Term Period
Death
|
1
|
1
|
|
Long Term Period
Lost to Follow-up
|
7
|
2
|
Baseline Characteristics
Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
Baseline characteristics by cohort
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel
|
Placebo
n=11 Participants
Placebo topical gel
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 12.48 • n=99 Participants
|
58.9 years
STANDARD_DEVIATION 13.20 • n=107 Participants
|
60.9 years
STANDARD_DEVIATION 12.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
11 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Ocular Graft versus Host Diagnosis
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Time of HSCT to oGvHD Diagnosis
|
27.5 months
STANDARD_DEVIATION 22.5 • n=99 Participants
|
40.0 months
STANDARD_DEVIATION 49.9 • n=107 Participants
|
31.6 months
STANDARD_DEVIATION 33.8 • n=206 Participants
|
|
NIH Eye Score
Score 0-1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
NIH Eye Score
Score 2
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
NIH Eye Score
Score 3
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Concomitant artificial tears and gel
|
21 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Concomitant ocular corticosteroid
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Concomitant ocular ciclosporin
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Punctal plugs history
|
18 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Concomitant systemic anti-inflammatory
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Frequency, Change From Baseline
|
-22.00 score on a scale
Standard Error 4.246
|
-4.59 score on a scale
Standard Error 6.009
|
PRIMARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Central, Change From Baseline
|
-0.90 score on a scale
Standard Error 0.213
|
0.20 score on a scale
Standard Error 0.304
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Frequency, Change From Baseline
|
-31.75 score on a scale
Standard Error 4.313
|
-1.95 score on a scale
Standard Error 6.009
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Frequency, Change From Baseline
|
-30.72 score on a scale
Standard Error 4.313
|
-2.18 score on a scale
Standard Error 6.009
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Central, Change From Baseline
|
-0.93 score on a scale
Standard Error 0.216
|
-0.01 score on a scale
Standard Error 0.304
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Central, Change From Baseline
|
-1.18 score on a scale
Standard Error 0.216
|
0.06 score on a scale
Standard Error 0.307
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Global, Change From Baseline
|
-16.02 score on a scale
Standard Error 4.063
|
-3.78 score on a scale
Standard Error 5.753
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Global, Change From Baseline
|
-26.35 score on a scale
Standard Error 4.128
|
-5.64 score on a scale
Standard Error 5.753
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Global, Change From Baseline
|
-25.87 score on a scale
Standard Error 4.128
|
-1.04 score on a scale
Standard Error 0.006
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Total, Change From Baseline
|
-2.53 score on a scale
Standard Error 0.527
|
-0.23 score on a scale
Standard Error 0.753
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Total, Change From Baseline
|
-3.28 score on a scale
Standard Error 0.537
|
-1.35 score on a scale
Standard Error 0.753
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Total, Change From Baseline
|
-3.97 score on a scale
Standard Error 0.537
|
-1.54 score on a scale
Standard Error 0.763
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Blurred Vision, Change From Baseline
|
-2.07 score on a scale
Standard Error 0.400
|
0.40 score on a scale
Standard Error 0.568
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Blurred Vision, Change From Baseline
|
-2.09 score on a scale
Standard Error 0.404
|
0.39 score on a scale
Standard Error 0.568
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Blurred Vision, Change From Baseline
|
-2.23 score on a scale
Standard Error 0.404
|
-0.31 score on a scale
Standard Error 0.568
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Photophobia, Change From Baseline
|
-1.23 score on a scale
Standard Error 0.432
|
0.18 score on a scale
Standard Error 0.695
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Photophobia, Change From Baseline
|
-1.68 score on a scale
Standard Error 0.437
|
0.62 score on a scale
Standard Error 0.613
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Photophobia, Change From Baseline
|
-1.82 score on a scale
Standard Error 0.437
|
0.01 score on a scale
Standard Error 0.612
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Edema, Change From Baseline
|
-1.73 score on a scale
Standard Error 0.206
|
-0.80 score on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Edema, Change From Baseline
|
-2.21 score on a scale
Standard Error 0.210
|
-0.98 score on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Edema, Change From Baseline
|
-1.72 score on a scale
Standard Error 0.210
|
-0.83 score on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Erythema, Change From Baseline
|
-1.08 score on a scale
Standard Error 0.224
|
-0.13 score on a scale
Standard Error 0.317
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Erythema, Change From Baseline
|
-1.53 score on a scale
Standard Error 0.229
|
-0.58 score on a scale
Standard Error 0.317
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Erythema, Change From Baseline
|
-1.42 score on a scale
Standard Error 0.229
|
-1.27 score on a scale
Standard Error 0.354
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Margin Ulceration, Change From Baseline
|
-1.14 score on a scale
Standard Error 0.240
|
-0.01 score on a scale
Standard Error 0.341
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Margin Ulceration, Change From Baseline
|
-1.57 score on a scale
Standard Error 0.245
|
-0.59 score on a scale
Standard Error 0.341
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Margin Ulceration, Change From Baseline
|
-1.85 score on a scale
Standard Error 0.245
|
-1.27 score on a scale
Standard Error 0.354
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Conjunctival Hyperemia, Change From Baseline
|
-1.50 score on a scale
Standard Error 0.235
|
-0.70 score on a scale
Standard Error 0.333
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Conjunctival Hyperemia, Change From Baseline
|
-1.75 score on a scale
Standard Error 0.240
|
-0.92 score on a scale
Standard Error 0.333
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Conjunctival Hyperemia, Change From Baseline
|
-1.72 score on a scale
Standard Error 0.240
|
-0.99 score on a scale
Standard Error 0.333
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Dryness, Change From Baseline
|
-2.48 score on a scale
Standard Error 0.391
|
-2.23 score on a scale
Standard Error 0.554
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Dryness, Change From Baseline
|
-2.91 score on a scale
Standard Error 0.398
|
-2.76 score on a scale
Standard Error 0.554
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Dryness, Change From Baseline
|
-3.67 score on a scale
Standard Error 0.398
|
-2.28 score on a scale
Standard Error 0.554
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Ocular Pain, Change From Baseline
|
-1.64 score on a scale
Standard Error 0.310
|
-0.29 score on a scale
Standard Error 0.439
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Ocular Pain, Change From Baseline
|
-1.53 score on a scale
Standard Error 0.316
|
-0.99 score on a scale
Standard Error 0.439
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Ocular Pain, Change From Baseline
|
-1.86 score on a scale
Standard Error 0.316
|
-1.06 score on a scale
Standard Error 0.499
|
SECONDARY outcome
Timeframe: 2 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Airflow Sensitivity, Change From Baseline
|
-1.93 score on a scale
Standard Error 0.401
|
-0.68 score on a scale
Standard Error 0.567
|
SECONDARY outcome
Timeframe: 6 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Airflow Sensitivity, Change From Baseline
|
-1.69 score on a scale
Standard Error 0.407
|
-0.53 score on a scale
Standard Error 0.583
|
SECONDARY outcome
Timeframe: 10 weeksChange in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=22 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=11 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Airflow Sensitivity, Change From Baseline
|
-1.76 score on a scale
Standard Error 0.407
|
-0.31 score on a scale
Standard Error 0.567
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: The total number of participants were combined in one group for the 1 year analysis as all participants were dosed with active Pro-ocular after 10 weeks.
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Frequency
|
82.03 units on a scale
Standard Deviation 11.719
|
33.04 units on a scale
Standard Deviation 27.517
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: The total number of participants were combined in one group for the 2 year analysis as all participants were dosed with active Pro-ocular after 10 weeks.
Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Frequency
|
82.03 units on a scale
Standard Deviation 11.719
|
35.29 units on a scale
Standard Deviation 27.637
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Global
|
74.39 units on a scale
Standard Deviation 16.620
|
32.63 units on a scale
Standard Deviation 24.407
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Modified SANDE Questionnaire - Global
|
74.39 units on a scale
Standard Deviation 16.620
|
31.04 units on a scale
Standard Deviation 22.037
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearFluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Central
|
3.57 units on a scale
Standard Deviation 2.779
|
1.12 units on a scale
Standard Deviation 1.522
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsFluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Central
|
3.57 units on a scale
Standard Deviation 2.779
|
0.77 units on a scale
Standard Deviation 1.224
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearFluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Total
|
11.52 units on a scale
Standard Deviation 7.137
|
3.65 units on a scale
Standard Deviation 3.289
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsFluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Corneal Fluorescein Stain - Total
|
11.52 units on a scale
Standard Deviation 7.137
|
2.81 units on a scale
Standard Deviation 3.699
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Blurred Vision
|
7.59 units on a scale
Standard Deviation 2.610
|
2.20 units on a scale
Standard Deviation 2.582
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Blurred Vision
|
7.59 units on a scale
Standard Deviation 2.610
|
1.66 units on a scale
Standard Deviation 2.768
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Edema
|
3.74 score on a scale
Standard Deviation 2.785
|
0.72 score on a scale
Standard Deviation 0.995
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Edema
|
3.74 score on a scale
Standard Deviation 2.785
|
0.71 score on a scale
Standard Deviation 1.085
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Erythema
|
3.92 score on a scale
Standard Deviation 2.738
|
1.17 score on a scale
Standard Deviation 1.457
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Erythema
|
3.92 score on a scale
Standard Deviation 2.738
|
0.80 score on a scale
Standard Deviation 1.144
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Ulceration
|
4.07 score on a scale
Standard Deviation 2.289
|
1.14 score on a scale
Standard Deviation 1.143
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Lid Ulceration
|
4.07 score on a scale
Standard Deviation 2.289
|
0.42 score on a scale
Standard Deviation 0.628
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=25 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Conjunctival Hyperemia
|
3.67 score on a scale
Standard Deviation 2.354
|
0.80 score on a scale
Standard Deviation 1.238
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsScore for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
Outcome measures
| Measure |
Pro-ocular™
n=33 Participants
Pro-ocular™ 1% topical gel forehead BID
|
Placebo
n=21 Participants
Placebo topical gel forehead tBID
|
|---|---|---|
|
Conjunctival Hyperemia
|
3.67 score on a scale
Standard Deviation 2.354
|
0.46 score on a scale
Standard Deviation 0.886
|
Adverse Events
Pro-ocular™ for 2 Years
Serious events: 8 serious events
Other events: 21 other events
Deaths: 1 deaths
Pro-ocular™ for 10-week Masked Period Only
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo+Active for 2 Years Total
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Placebo for 10-week Masked Period Ony
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pro-ocular™ for 2 Years
n=22 participants at risk
Pro-ocular™ 1% topical gel applied to forehead twice daily
|
Pro-ocular™ for 10-week Masked Period Only
n=22 participants at risk
Pro-ocular™ 1% topical gel applied to forehead twice daily for 10-week masked period only
|
Placebo+Active for 2 Years Total
n=11 participants at risk
Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period, followed by active gel for the remaining 2 year period
|
Placebo for 10-week Masked Period Ony
n=11 participants at risk
Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period only
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
18.2%
2/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Blood and lymphatic system disorders
Acute lymphocytic leukaemia recurrent
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasm
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Surgical and medical procedures
Vascular operation
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Surgical and medical procedures
Hip surgery
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Cardiac disorders
Dyspnea
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Corneal perforation
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Corneal thinning
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 3 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Cardiac disorders
Mycardial infarction
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Vascular disorders
Cerebrovascular accident
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Cardiac disorders
Angina unstable
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Ophthalmic herpes simplex
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Corneal infiltrates
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Surgical and medical procedures
Parathyroidectomy
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
Other adverse events
| Measure |
Pro-ocular™ for 2 Years
n=22 participants at risk
Pro-ocular™ 1% topical gel applied to forehead twice daily
|
Pro-ocular™ for 10-week Masked Period Only
n=22 participants at risk
Pro-ocular™ 1% topical gel applied to forehead twice daily for 10-week masked period only
|
Placebo+Active for 2 Years Total
n=11 participants at risk
Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period, followed by active gel for the remaining 2 year period
|
Placebo for 10-week Masked Period Ony
n=11 participants at risk
Placebo topical gel applied to forehead twice daily. Placebo gel for the first 10 weeks of masked period only
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
27.3%
6/22 • Number of events 6 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
27.3%
6/22 • Number of events 6 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
27.3%
6/22 • Number of events 11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
27.3%
6/22 • Number of events 11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.1%
2/22 • Number of events 3 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Corneal abrasion
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Eye pain
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
18.2%
2/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
18.2%
2/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Eye pruritus
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Vitreous floaters
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
18.2%
2/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
27.3%
3/11 • Number of events 3 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
General disorders
Discomfort
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
2/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/22 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
General disorders
Fatigue
|
4.5%
1/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
18.2%
2/11 • Number of events 2 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
4.5%
1/22 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
9.1%
1/11 • Number of events 1 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
0.00%
0/11 • 2 years
The entire study period of 2 years include a masked phase of 10 weeks, after which all participants received active drug for the remaining 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has prior review rights before publications or presentations.
- Publication restrictions are in place
Restriction type: OTHER