Dry Eye Disease
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).
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 subjects with dry eye disease. Approximately 45 subjects, at least 22 years of age, with a 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 twice daily (BID) for 4 weeks.
Interventions
DRUGOC-02 (simpinicline) nasal spray
OC-02 (simpinicline) nasal spray, 11.1 mg/ml
Placebo (vehicle) nasal spray
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 60 days 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 (e.g. laser epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive keratectomy or corneal implant) 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 dry eye disease 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 |
|---|---|---|
| Mean Change in Schirmer's Test From Baseline to 28 Days | 28 days [Visit 1 (baseline) and Visit 5 (28 Days)] | The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-02. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray, 11.1 mg/ml
OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml | 34 |
| Placebo Placebo (vehicle) nasal spray
Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray | 19 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 11.5 | 63.7 years STANDARD_DEVIATION 12.7 | 63.2 years STANDARD_DEVIATION 13.5 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 18 Participants | 49 Participants | 31 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 48 Participants | 29 Participants |
| Region of Enrollment United States | 19 participants | 53 participants | 34 participants |
| Schirmer's Test | 5.1 mm STANDARD_DEVIATION 3.1 | 5.9 mm STANDARD_DEVIATION 3.1 | 6.3 mm STANDARD_DEVIATION 3.1 |
| Sex: Female, Male Female | 15 Participants | 42 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 19 |
| other Total, other adverse events | 33 / 34 | 11 / 19 |
| serious Total, serious adverse events | 0 / 34 | 0 / 19 |
Outcome results
Primary
Mean Change in Schirmer's Test From Baseline to 28 Days
The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-02. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.
Time frame: 28 days [Visit 1 (baseline) and Visit 5 (28 Days)]
Population: Subjects in the ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Mean Change in Schirmer's Test From Baseline to 28 Days | 10.5 mm |
| Placebo | Mean Change in Schirmer's Test From Baseline to 28 Days | 5.7 mm |