Trial Outcomes & Findings for Topical rVA576 for Treatment of Atopic Keratoconjunctivitis (NCT NCT04037891)
NCT ID: NCT04037891
Last Updated: 2025-04-10
Results Overview
Incidence of ocular treatment-emergent adverse events (TEAE) during the treatment period which have occurred during the 56 days following randomisation.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
56 days
Results posted on
2025-04-10
Participant Flow
Patients in Part 1 did not continue into Part 2.
Participant milestones
| Measure |
rVA576, Open-label Period (8 Weeks)
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
Patients in Part 1 did not continue into Part 2.
|
rVA576, Double-blind Period (8 Weeks)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (8 Weeks)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|
|
Open-label Period
STARTED
|
3
|
0
|
0
|
|
Open-label Period
COMPLETED
|
2
|
0
|
0
|
|
Open-label Period
NOT COMPLETED
|
1
|
0
|
0
|
|
Randomized, Double-blind Period
STARTED
|
0
|
3
|
6
|
|
Randomized, Double-blind Period
COMPLETED
|
0
|
2
|
6
|
|
Randomized, Double-blind Period
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
rVA576, Open-label Period (8 Weeks)
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
Patients in Part 1 did not continue into Part 2.
|
rVA576, Double-blind Period (8 Weeks)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (8 Weeks)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|
|
Open-label Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Randomized, Double-blind Period
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
Baseline characteristics by cohort
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 11.55 • n=99 Participants
|
30.3 years
STANDARD_DEVIATION 6.81 • n=107 Participants
|
33.8 years
STANDARD_DEVIATION 8.04 • n=206 Participants
|
32.7 years
STANDARD_DEVIATION 7.42 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Indication
Atopic keratoconjunctivitis (AKC)
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Indication
Vernal keratoconjunctivitis (VKC)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Indication
Seasonal allergic conjunctivitis (SAC)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Indication
Perennial allergic conjunctivitis (PAC)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Patient group
AKC/VKC
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Patient group
SAC/PAC
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 56 daysIncidence of ocular treatment-emergent adverse events (TEAE) during the treatment period which have occurred during the 56 days following randomisation.
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
Incidence of Ocular TEAE
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 56Population: The Comfort score data was not available for one patient in the nomacopan group Part 2, and in one patient in Part 1, after Day 14, both due to withdrawal. Because only two patients in the Part 2 nomacopan group had data to assess comfort score, it is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed.
Graded on patient diary cards at the intervals Day 1-14, 15-28, 29-42 and 43-56. Eye comfort scoring: 0 - Perfectly comfortable 1. \- Slight discomfort. Some burning, itching or stinging for up to half a minute after using the eye drop, solution but the discomfort improves without treatment. 2. \- Moderate discomfort. Burning, itching or stinging lasts for 0.5 minute or longer but improves without treatment. 3. \- Severe discomfort. Burning, itching or stinging last for at least 0.5 minute and requires washing the eyes to relieve it. 4. \- Unbearable burning itching or stinging. So severe that you cannot continue treatment. The 14 day average score for each interval have been calculated for each patient (possible range of 0 to 40). Classifications were assigned using the average total score at each two week period as follows: \< 10 = Comfortable/Acceptable, 10 - 19 = Moderately Uncomfortable, 20 - 29 = Very Uncomfortable, \>= 30 = Severely/Unacceptably Uncomfortable.
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
Post-instillation Comfort
Day 1 to 14 · Comfortable/Acceptable
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Post-instillation Comfort
Day 1 to 14 · Moderately Uncomfortable
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Post-instillation Comfort
Days 15 to 28 · Comfortable/Acceptable
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Post-instillation Comfort
Days 15 to 28 · Moderately Uncomfortable
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Post-instillation Comfort
Days 29 to 42 · Comfortable/Acceptable
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Post-instillation Comfort
Days 29 to 42 · Moderately Uncomfortable
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Post-instillation Comfort
Days 43 to 56 · Comfortable/Acceptable
|
2 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Post-instillation Comfort
Days 43 to 56 · Moderately Uncomfortable
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 56Population: Only one patient in the nomacopan group in Part 2 had data to assess this score. It is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed.
Visual acuity for the worst eye over time by Early Treatment Diabetic Retinopathy Study (ETDRS) charts comparison from Day 1 to Day 56 In ETDRS charts, zero indicates standard vision, positive values indicates poor vision, and negative values indicates good vision.
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
Visual Acuity
Day 28
|
84.0 Number of ETDRS letters
Standard Deviation 0.0
|
78.0 Number of ETDRS letters
Standard Deviation 0
|
79.8 Number of ETDRS letters
Standard Deviation 10.68
|
—
|
|
Visual Acuity
Baseline
|
56.7 Number of ETDRS letters
Standard Deviation 49.1
|
66.0 Number of ETDRS letters
Standard Deviation 19.8
|
82.7 Number of ETDRS letters
Standard Deviation 8.778
|
—
|
|
Visual Acuity
Day 14
|
59.0 Number of ETDRS letters
Standard Deviation 48.5
|
82.0 Number of ETDRS letters
Standard Deviation 0
|
82.0 Number of ETDRS letters
Standard Deviation 7.18
|
—
|
|
Visual Acuity
Day 42
|
85.5 Number of ETDRS letters
Standard Deviation 0.7
|
83.0 Number of ETDRS letters
Standard Deviation 0
|
79.3 Number of ETDRS letters
Standard Deviation 15.33
|
—
|
|
Visual Acuity
Day 56 (end of dosing)
|
87.0 Number of ETDRS letters
Standard Deviation 1.4
|
81.0 Number of ETDRS letters
Standard Deviation 0
|
77.0 Number of ETDRS letters
Standard Deviation 10.56
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 56Population: Because only two patients in the Part 2 nomacopan group had data to assess this score, it is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed. Note there were two patients on Placebo with SAC; therefore, scored on a different scale compared to patients with AKC or VKC. For the purposes of the outcome measure, the SAC and AKC/VKC scores were combined to derive a single value across all participants.
Change from Day 1 in composite clinical scores at Day 14, 28, 42 and 56, for the eye judged as worst affected at each visit. Score calculated from symptom and sign sub-components. AKC/VKC: symptom sub-component consisted of itch, tearing, discomfort, discharge, and photophobia, and the sign component consisted of bulbar conjunctival hyperaemia, tarsal conjunctival papillary hypertrophy, punctate keratitis, neovascularization of cornea, cicatrizing conjunctivitis, blepharitis. SAC/PAC: symptom sub-component consisted itch, tearing, discomfort, and photophobia, and the sign sub-component consisted of upper tarsal conjunctival hyperaemia, upper bulbar conjunctival hyperaemia, chemosis, upper tarsal conjunctival papillae, blepharitis. For each sign/symptom a score of 0 - 3 is awarded (0=absence of a sign/symptom; an increase in score indicates increase in severity). These scores are summed at the end of the exam to give the composite score. Range:0 to 33 (AKC/VKC) or 27 (SAC/PAC).
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=4 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
n=2 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
Clinical Scores
Baseline
|
23.2 score on a scale
Standard Deviation 1.53
|
20.7 score on a scale
Standard Deviation 2.31
|
21.3 score on a scale
Standard Deviation 1.26
|
19.5 score on a scale
Standard Deviation 3.54
|
|
Clinical Scores
Day 14
|
16.0 score on a scale
Standard Deviation 5.20
|
15.0 score on a scale
Standard Deviation 1.41
|
14.8 score on a scale
Standard Deviation 3.5
|
17.5 score on a scale
Standard Deviation 6.36
|
|
Clinical Scores
Day 28
|
14.5 score on a scale
Standard Deviation 0.71
|
19.0 score on a scale
Standard Deviation 7.07
|
15 score on a scale
Standard Deviation 5.48
|
17.5 score on a scale
Standard Deviation 7.78
|
|
Clinical Scores
Day 42
|
16.0 score on a scale
Standard Deviation 7.07
|
16.5 score on a scale
Standard Deviation 2.12
|
11.8 score on a scale
Standard Deviation 5.32
|
—
|
|
Clinical Scores
Day 56
|
10.5 score on a scale
Standard Deviation 0.71
|
15.0 score on a scale
Standard Deviation 1.41
|
11.0 score on a scale
Standard Deviation 7.28
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 56Population: There were too few patients to make a meaningful interpretation.
Percentage of patients with Matrix metalloprotease 9 (MMP-9) positive levels at Days 1, 28, and 56. MMP-9 is a is a nonspecific inflammatory marker. Detection was made using the Inflammadry® device. This device gives a binary (positive/negative) result.
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
MMP-9 Positive
Baseline right eye · Negative
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
|
MMP-9 Positive
Day 56 right eye · Negative
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
|
MMP-9 Positive
Baseline left eye · Positive
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
|
MMP-9 Positive
Baseline left eye · Negative
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
MMP-9 Positive
Baseline right eye · Positive
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
|
MMP-9 Positive
Day 28 left eye · Positive
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
|
MMP-9 Positive
Day 28 left eye · Negative
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
|
MMP-9 Positive
Day 28 right eye · Positive
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
MMP-9 Positive
Day 28 right eye · Negative
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
|
MMP-9 Positive
Day 56 left eye · Positive
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
MMP-9 Positive
Day 56 left eye · Negative
|
1 Participants
|
1 Participants
|
5 Participants
|
—
|
|
MMP-9 Positive
Day 56 right eye · Positive
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Change from Day 1 at Day 14, 28, 42 and 56Population: Patient numbers within each treatment group are too small to make meaningful comparisons, and so no further analysis was performed.
Change from Day 1 in Tear film break up time (TBUT) at Day 14, 28, 42 and 56. TBUT data was available for one eye only. Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. A TBUT under 10 seconds is considered abnormal.
Outcome measures
| Measure |
rVA576, Open-label Period
n=3 Participants
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 Participants
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo (SAC/PAC)
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|---|
|
Tear Film Break up Time
Baseline
|
5.0 seconds
Standard Deviation 5.57
|
3.0 seconds
Standard Deviation 1.00
|
3.5 seconds
Standard Deviation 1.05
|
—
|
|
Tear Film Break up Time
Day 14
|
6.0 seconds
Standard Deviation 3.61
|
2.5 seconds
Standard Deviation 0.71
|
3.7 seconds
Standard Deviation 2.25
|
—
|
|
Tear Film Break up Time
Day 28
|
11.0 seconds
Standard Deviation 1.41
|
4.5 seconds
Standard Deviation 0.71
|
5.0 seconds
Standard Deviation 2.00
|
—
|
|
Tear Film Break up Time
Day 42
|
8.0 seconds
Standard Deviation 0.00
|
4.0 seconds
Standard Deviation 0.00
|
8.0 seconds
Standard Deviation 2.16
|
—
|
|
Tear Film Break up Time
Day 56
|
6.5 seconds
Standard Deviation 2.12
|
5.0 seconds
Standard Deviation 0.00
|
7.4 seconds
Standard Deviation 1.95
|
—
|
Adverse Events
rVA576, Open-label Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
rVA576, Double-blind Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rVA576, Open-label Period
n=3 participants at risk
Part 1: The first three patients selected were treated with active drug in an open-label manner. They had weekly clinic visits for up the first two weeks and thereafter biweekly visits. When the third of the first three patients had completed their first two weeks of treatment, the PI reviewed the safety, tolerability, and ease of application for each patient before deciding to proceed to the randomised, double masked comparative phase of the study (Part 2). The three patients were to continue on the study and complete eight weeks of treatment as open-label patients.
|
rVA576, Double-blind Period
n=3 participants at risk
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
Placebo
n=6 participants at risk
Part 2: A randomised, double-masked, placebo controlled trial of topical rVA576, or placebo eye drops in moderate to severe AKC, VKC and severe allergic conjunctivitis (SAC or PAC).
|
|---|---|---|---|
|
Eye disorders
Atopic keratoconjunctivitis
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
33.3%
1/3 • Number of events 2 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • From day 1 to day 56.
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
16.7%
1/6 • Number of events 1 • From day 1 to day 56.
|
|
Eye disorders
Ocular hyperaemia
|
66.7%
2/3 • Number of events 2 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
16.7%
1/6 • Number of events 1 • From day 1 to day 56.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From day 1 to day 56.
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/3 • From day 1 to day 56.
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Eye discharge
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Eye pruritus
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Eye swelling
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
16.7%
1/6 • Number of events 1 • From day 1 to day 56.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
33.3%
1/3 • Number of events 1 • From day 1 to day 56.
|
0.00%
0/3 • From day 1 to day 56.
|
0.00%
0/6 • From day 1 to day 56.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60