Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye, Dry Eye Syndrome, SkQ1, Keratoconjunctivitis, Dry Eye Disease
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
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution). The following primary endpoints were tested: * Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline; * Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.
Interventions
DRUGLow Dose 0.155µg/mL SkQ1 ophthalmic solution
eyedrops
DRUGHigh Dose 1.55µg/mL SkQ1 ophthalmic solution
eyedrops
DRUGPlacebo (Vehicle) opthalmic solution
eyedrops
Sponsors
ORA, Inc.
Mitotech, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be male or female of any race, at least 18 years of age * Have provided written informed consent * Have a reported history of dry eye syndrome * Have a history of use or desire to use eye drops for dry eye
Exclusion criteria
* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters * Have previously had LASIK surgery within the last 12 months * Have used Restasis® within 30 days of Visit 1 * Be a woman who is pregnant, nursing or planning a pregnancy * Be unwilling to submit a urine pregnancy test if of childbearing potential * Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride * Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inferior Corneal Fluorescein Staining | Day 29 | 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 |
| Worst Symptom Based on Diary Data | Day 29 | Worst 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose - SkQ1 Low Dose 0.155 μg/mL SkQ1 ophthalmic solution | 30 |
| High Dose - SkQ1 High Dose 1.55 μg/mL SkQ1 ophthalmic solution | 30 |
| Placebo (Vehicle) Placebo (vehicle) ophthalmic solution | 31 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 4 | 1 |
Baseline characteristics
| Characteristic | High Dose - SkQ1 | Placebo (Vehicle) | Low Dose - SkQ1 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 21 Participants | 10 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 10 Participants | 20 Participants | 49 Participants |
| Age, Continuous | 59.5 years STANDARD_DEVIATION 11.69 | 64.6 years STANDARD_DEVIATION 9.76 | 61.9 years STANDARD_DEVIATION 10.25 | 62 years STANDARD_DEVIATION 10.68 |
| Region of Enrollment United States | 30 participants | 31 participants | 30 participants | 91 participants |
| Sex: Female, Male Female | 21 Participants | 25 Participants | 21 Participants | 67 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 30 | 1 / 30 | 3 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 31 |
Outcome results
Primary
Inferior Corneal Fluorescein Staining
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
Time frame: Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose SkQ1 | Inferior Corneal Fluorescein Staining | 2.40 units on a scale | Standard Deviation 0.675 |
| High Dose SkQ1 | Inferior Corneal Fluorescein Staining | 2.07 units on a scale | Standard Deviation 0.704 |
| Placebo (Vehicle) | Inferior Corneal Fluorescein Staining | 2.11 units on a scale | Standard Deviation 0.771 |
Primary
Worst Symptom Based on Diary Data
Worst 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.
Time frame: Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose SkQ1 | Worst Symptom Based on Diary Data | 2.54 units on a scale | Standard Deviation 0.993 |
| High Dose SkQ1 | Worst Symptom Based on Diary Data | 2.52 units on a scale | Standard Deviation 0.899 |
| Placebo (Vehicle) | Worst Symptom Based on Diary Data | 2.39 units on a scale | Standard Deviation 1.063 |