Dry Eye Disease
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Detailed description
This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.
Interventions
Placebo (vehicle) nasal spray
DRUG0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
DRUG1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
DRUG2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Sponsors
Oyster Point Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1
Exclusion criteria
* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1 * Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed. * Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.) * Have a known hypersensitivity to any of the procedural agents or study drug components * Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's Test Score at Day 1 | Day 1 (Pre to Post-Treatment Change) | The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome. |
| Eye Dryness Score at Visit 2 | Day 15 (Pre to Post-Treatment Change) | Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 41 |
| 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 41 |
| 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 41 |
| Placebo (Vehicle) Nasal Spray Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray | 42 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative reason | 0 | 0 | 1 | 1 |
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo (Vehicle) Nasal Spray | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) |
|---|---|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 10.97 | 64.4 years STANDARD_DEVIATION 11.76 | 62.7 years STANDARD_DEVIATION 9.3 | 64.4 years STANDARD_DEVIATION 11.8 | 64.0 years STANDARD_DEVIATION 11.15 |
| Race/Ethnicity, Customized American Indian Alaskan Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 11 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple races | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 161 Participants | 39 Participants | 41 Participants | 41 Participants | 40 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 150 Participants | 39 Participants | 37 Participants | 37 Participants | 37 Participants |
| Region of Enrollment United States | 165 participants | 42 participants | 41 participants | 41 participants | 41 participants |
| Sex: Female, Male Female | 118 Participants | 34 Participants | 31 Participants | 24 Participants | 29 Participants |
| Sex: Female, Male Male | 47 Participants | 8 Participants | 10 Participants | 17 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 17 / 41 | 23 / 41 | 24 / 41 | 4 / 42 |
| serious Total, serious adverse events | 1 / 41 | 0 / 41 | 0 / 41 | 0 / 42 |
Outcome results
Primary
Eye Dryness Score at Visit 2
Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Time frame: Day 15 (Pre to Post-Treatment Change)
Population: Subjects in the ITT Population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | Eye Dryness Score at Visit 2 | -9.4 mm |
| 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | Eye Dryness Score at Visit 2 | -17.4 mm |
| 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | Eye Dryness Score at Visit 2 | -20.7 mm |
| Placebo (Vehicle) Nasal Spray | Eye Dryness Score at Visit 2 | -6.5 mm |
Primary
Schirmer's Test Score at Day 1
The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: Day 1 (Pre to Post-Treatment Change)
Population: Subjects in the ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | Schirmer's Test Score at Day 1 | 9.0 mm |
| 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | Schirmer's Test Score at Day 1 | 17.5 mm |
| 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | Schirmer's Test Score at Day 1 | 19.6 mm |
| Placebo (Vehicle) Nasal Spray | Schirmer's Test Score at Day 1 | 3.0 mm |