Trial Outcomes & Findings for A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES) (NCT NCT02121301)
NCT ID: NCT02121301
Last Updated: 2020-11-02
Results Overview
The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Day 29
Results posted on
2020-11-02
Participant Flow
Participant milestones
| Measure |
Low Dose SkQ1
Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
|
High Dose SkQ1
High Dose 1.55 μg/mL SkQ1 ophthalmic solution
|
Placebo (Vehicle)
Placebo (vehicle) ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Low Dose SkQ1
Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
|
High Dose SkQ1
High Dose 1.55 μg/mL SkQ1 ophthalmic solution
|
Placebo (Vehicle)
Placebo (vehicle) ophthalmic solution
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
4
|
1
|
Baseline Characteristics
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Baseline characteristics by cohort
| Measure |
Low Dose - SkQ1
n=30 Participants
Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
|
High Dose - SkQ1
n=30 Participants
High Dose 1.55 μg/mL SkQ1 ophthalmic solution
|
Placebo (Vehicle)
n=31 Participants
Placebo (vehicle) ophthalmic solution
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 29The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Outcome measures
| Measure |
Low Dose SkQ1
n=30 Participants
Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
|
High Dose SkQ1
n=30 Participants
High Dose 1.55 μg/mL SkQ1 ophthalmic solution
|
Placebo (Vehicle)
n=31 Participants
Placebo (vehicle) ophthalmic solution
|
|---|---|---|---|
|
Inferior Corneal Fluorescein Staining
|
2.40 units on a scale
Standard Deviation 0.675
|
2.07 units on a scale
Standard Deviation 0.704
|
2.11 units on a scale
Standard Deviation 0.771
|
PRIMARY outcome
Timeframe: Day 29Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.
Outcome measures
| Measure |
Low Dose SkQ1
n=30 Participants
Low Dose 0.155 μg/mL SkQ1 ophthalmic solution
|
High Dose SkQ1
n=30 Participants
High Dose 1.55 μg/mL SkQ1 ophthalmic solution
|
Placebo (Vehicle)
n=31 Participants
Placebo (vehicle) ophthalmic solution
|
|---|---|---|---|
|
Worst Symptom Based on Diary Data
|
2.54 units on a scale
Standard Deviation 0.993
|
2.52 units on a scale
Standard Deviation 0.899
|
2.39 units on a scale
Standard Deviation 1.063
|
Adverse Events
Low Dose SkQ1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Dose SkQ1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Vehicle)
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 |
Low Dose SkQ1
n=30 participants at risk
Low Dose 0.155 µg/mL SkQ1 opthalmic solution
|
High Dose SkQ1
n=30 participants at risk
High Dose 1.55 µg/mL SkQ1 opthalmic solution
|
Placebo (Vehicle)
n=31 participants at risk
Placebo (vehicle) ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
discomfort
|
3.3%
1/30 • Number of events 1 • From dilating drop at Day -7 through end of study (Day 29)
|
3.3%
1/30 • Number of events 1 • From dilating drop at Day -7 through end of study (Day 29)
|
9.7%
3/31 • Number of events 3 • From dilating drop at Day -7 through end of study (Day 29)
|
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