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 solutions are safe and effective compared to placebo 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 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining; Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom
Interventions
DRUGLow Dose - SkQ1
SkQ1 Low dose ophthalmic solution
DRUGHigh dose - SkQ1
SkQ1 High Dose ophthalmic solution
DRUGSkQ1 (Vehicle)
Vehicle for 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-group study of two strengths of ophthalmic solution versus placebo 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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study; * 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 |
|---|---|---|
| Central Corneal Staining Change From Baseline | From baseline to Day 57 | Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe |
| Grittiness Change From Baseline | From baseline to Day 57 | Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SkQ1 Vehicle Vehicle for SkQ1 ophthalmic solution | 151 |
| Low Dose - SkQ1 SkQ1 Low dose ophthalmic solution | 149 |
| High Dose - SkQ1 SkQ1 High Dose ophthalmic solution | 151 |
| Total | 451 |
Baseline characteristics
| Characteristic | SkQ1 Vehicle | Low Dose - SkQ1 | High Dose - SkQ1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 83 Participants | 75 Participants | 64 Participants | 222 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 74 Participants | 87 Participants | 229 Participants |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 12.98 | 64.4 years STANDARD_DEVIATION 12.35 | 61.4 years STANDARD_DEVIATION 13.58 | 63.4 years STANDARD_DEVIATION 13.03 |
| Central CFS | 1.72 units on a scale STANDARD_DEVIATION 0.73 | 1.67 units on a scale STANDARD_DEVIATION 0.69 | 1.67 units on a scale STANDARD_DEVIATION 0.68 | 1.69 units on a scale STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 14 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 142 Participants | 137 Participants | 424 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 14 Participants | 24 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 124 Participants | 130 Participants | 120 Participants | 374 Participants |
| Region of Enrollment United States | 151 Participants | 149 Participants | 151 Participants | 451 Participants |
| Sex: Female, Male Female | 115 Participants | 99 Participants | 102 Participants | 316 Participants |
| Sex: Female, Male Male | 36 Participants | 50 Participants | 49 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 149 | 0 / 151 |
| other Total, other adverse events | 3 / 151 | 4 / 149 | 3 / 151 |
| serious Total, serious adverse events | 1 / 151 | 3 / 149 | 2 / 151 |
Outcome results
Primary
Central Corneal Staining Change From Baseline
Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Time frame: From baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SkQ1 Vehicle | Central Corneal Staining Change From Baseline | -0.28 score on a scale | Standard Deviation 0.773 |
| Low Dose - SkQ1 | Central Corneal Staining Change From Baseline | -0.3 score on a scale | Standard Deviation 0.816 |
| High Dose - SkQ1 | Central Corneal Staining Change From Baseline | -0.2 score on a scale | Standard Deviation 0.763 |
Primary
Grittiness Change From Baseline
Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst
Time frame: From baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SkQ1 Vehicle | Grittiness Change From Baseline | -0.42 score on a scale | Standard Deviation 1.108 |
| Low Dose - SkQ1 | Grittiness Change From Baseline | -0.36 score on a scale | Standard Deviation 1.176 |
| High Dose - SkQ1 | Grittiness Change From Baseline | -0.43 score on a scale | Standard Deviation 1.387 |