Trial Outcomes & Findings for Study of SkQ1 as Treatment for Dry-eye Syndrome (NCT NCT03764735)
NCT ID: NCT03764735
Last Updated: 2022-01-19
Results Overview
Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
From baseline to Day 57
Results posted on
2022-01-19
Participant Flow
Participant milestones
| Measure |
SkQ1 Vehicle
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
SkQ1 High Dose ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
151
|
150
|
151
|
|
Overall Study
COMPLETED
|
147
|
144
|
147
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SkQ1 as Treatment for Dry-eye Syndrome
Baseline characteristics by cohort
| Measure |
SkQ1 Vehicle
n=151 Participants
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
n=149 Participants
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
n=151 Participants
SkQ1 High Dose ophthalmic solution
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
229 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
222 Participants
n=157 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 12.98 • n=99 Participants
|
64.4 years
STANDARD_DEVIATION 12.35 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 13.58 • n=206 Participants
|
63.4 years
STANDARD_DEVIATION 13.03 • n=157 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
316 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
135 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
27 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
424 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
61 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
374 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
151 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
451 Participants
n=157 Participants
|
|
Central CFS
|
1.72 units on a scale
STANDARD_DEVIATION 0.73 • n=99 Participants
|
1.67 units on a scale
STANDARD_DEVIATION 0.69 • n=107 Participants
|
1.67 units on a scale
STANDARD_DEVIATION 0.68 • n=206 Participants
|
1.69 units on a scale
STANDARD_DEVIATION 0.70 • n=157 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 57Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Outcome measures
| Measure |
SkQ1 Vehicle
n=151 Participants
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
n=149 Participants
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
n=151 Participants
SkQ1 High Dose ophthalmic solution
|
|---|---|---|---|
|
Central Corneal Staining Change From Baseline
|
-0.28 score on a scale
Standard Deviation 0.773
|
-0.3 score on a scale
Standard Deviation 0.816
|
-0.2 score on a scale
Standard Deviation 0.763
|
PRIMARY outcome
Timeframe: From baseline to Day 57Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst
Outcome measures
| Measure |
SkQ1 Vehicle
n=151 Participants
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
n=149 Participants
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
n=151 Participants
SkQ1 High Dose ophthalmic solution
|
|---|---|---|---|
|
Grittiness Change From Baseline
|
-0.42 score on a scale
Standard Deviation 1.108
|
-0.36 score on a scale
Standard Deviation 1.176
|
-0.43 score on a scale
Standard Deviation 1.387
|
Adverse Events
SkQ1 Vehicle
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Dose - SkQ1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose - SkQ1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SkQ1 Vehicle
n=151 participants at risk
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
n=149 participants at risk
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
n=151 participants at risk
SkQ1 High Dose ophthalmic solution
|
|---|---|---|---|
|
Reproductive system and breast disorders
Ovarian cancer
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
0.67%
1/149 • From Day -7 through end of study (Day 57)
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
|
Vascular disorders
Peripheral arterial occlusive disorder
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
0.67%
1/149 • From Day -7 through end of study (Day 57)
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
0.00%
0/149 • From Day -7 through end of study (Day 57)
|
0.66%
1/151 • From Day -7 through end of study (Day 57)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
0.00%
0/149 • From Day -7 through end of study (Day 57)
|
0.66%
1/151 • From Day -7 through end of study (Day 57)
|
|
Surgical and medical procedures
Procedural pain
|
0.66%
1/151 • From Day -7 through end of study (Day 57)
|
0.00%
0/149 • From Day -7 through end of study (Day 57)
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
|
Nervous system disorders
Migraine
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
0.67%
1/149 • From Day -7 through end of study (Day 57)
|
0.00%
0/151 • From Day -7 through end of study (Day 57)
|
Other adverse events
| Measure |
SkQ1 Vehicle
n=151 participants at risk
Vehicle for SkQ1 ophthalmic solution
|
Low Dose - SkQ1
n=149 participants at risk
SkQ1 Low dose ophthalmic solution
|
High Dose - SkQ1
n=151 participants at risk
SkQ1 High Dose ophthalmic solution
|
|---|---|---|---|
|
General disorders
Instillation site pain
|
1.3%
2/151 • From Day -7 through end of study (Day 57)
|
2.7%
4/149 • From Day -7 through end of study (Day 57)
|
2.0%
3/151 • From Day -7 through end of study (Day 57)
|
|
Eye disorders
Visual acuity reduced
|
0.66%
1/151 • From Day -7 through end of study (Day 57)
|
0.00%
0/149 • From Day -7 through end of study (Day 57)
|
2.0%
3/151 • From Day -7 through end of study (Day 57)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.
- Publication restrictions are in place
Restriction type: OTHER