Dry Eye Syndrome
Conditions
Keywords
Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis
Brief summary
The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.
Detailed description
Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort; Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)
Interventions
DRUGSkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
DRUGSkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution
Sponsors
ORA, Inc.
Mitotech, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye; * Have a history of use of eye drops for dry eye symptoms; * Ocular Discomfort; * Schirmer's Test score; * Have corneal fluorescein staining ; * Have lissamine green conjunctival Staining; * Have a conjunctival redness;
Exclusion criteria
* Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment; * Have any clinically significant slit lamp findings at Visit 1; * Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1; * Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period; * Have an uncontrolled systemic disease; * Be a woman who is pregnant, nursing or planning a pregnancy; * Be a woman of childbearing potential who is not using an acceptable means of birth control; * Have a known allergy and/or sensitivity to the study drug or its components; * Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Discomfort Scale | From baseline to Day 57 | Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort. |
| Conjunctival Fluorescein Staining | From baseline to Day 57 | Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Comparator: SkQ1 Vehicle Vehicle for SkQ1 Ophthalmic Solution | 306 |
| SkQ1 Ophthalmic Solution SkQ1 Ophthalmic Solution (1.55µg/mL) | 304 |
| Total | 610 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Unable to attend visits | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo Comparator: SkQ1 Vehicle | SkQ1 Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 140 Participants | 154 Participants | 294 Participants |
| Age, Categorical Between 18 and 65 years | 166 Participants | 150 Participants | 316 Participants |
| Age, Continuous Mean (SD) | 61.9 years STANDARD_DEVIATION 11.92 | 62.8 years STANDARD_DEVIATION 12.58 | 62.4 years STANDARD_DEVIATION 12.25 |
| Ocular Discomfort Scale | 2.7 units on a scale STANDARD_DEVIATION 1.06 | 2.7 units on a scale STANDARD_DEVIATION 0.98 | 2.7 units on a scale STANDARD_DEVIATION 1.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 34 Participants | 84 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 241 Participants | 253 Participants | 494 Participants |
| Region of Enrollment United States | 306 participants | 304 participants | 610 participants |
| Sex: Female, Male Female | 223 Participants | 209 Participants | 432 Participants |
| Sex: Female, Male Male | 83 Participants | 95 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 306 | 0 / 304 |
| other Total, other adverse events | 19 / 306 | 20 / 304 |
| serious Total, serious adverse events | 2 / 306 | 2 / 304 |
Outcome results
Primary
Conjunctival Fluorescein Staining
Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining
Time frame: From baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Comparator: SkQ1 Vehicle | Conjunctival Fluorescein Staining | -0.63 units on a scale | Standard Deviation 1.087 |
| SkQ1 Ophthalmic Solution | Conjunctival Fluorescein Staining | -0.69 units on a scale | Standard Deviation 1.15 |
Primary
Ocular Discomfort Scale
Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Time frame: From baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Comparator: SkQ1 Vehicle | Ocular Discomfort Scale | -0.6 units on a scale | Standard Deviation 1.36 |
| SkQ1 Ophthalmic Solution | Ocular Discomfort Scale | -0.6 units on a scale | Standard Deviation 1.34 |