A Phase 2 interventional study of OC-02 (simpinicline) nasal spray and Placebo (vehicle) nasal spray in Dry Eye Disease, sponsored by Oyster Point Pharma, Inc.. Completed at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Oyster Point Pharma, Inc. · Phase 2, Interventional, and Treatment
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).
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 53 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Oyster Point Pharma, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OC-02 (simpinicline) nasal spray, 11.1 mg/ml
Drug: OC-02 (simpinicline) nasal spray
Placebo (vehicle) nasal spray
Drug: Placebo (vehicle) nasal spray
OC-02 (simpinicline) nasal spray, 11.1 mg/ml
Also known as: OC-02 (simpinicline) nasal spray, 11.1 mg/ml
Placebo (vehicle) nasal spray
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)]
| Milestone | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo |
|---|---|---|
| Started | 34 | 19 |
| Completed | 34 | 18 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| mm | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo |
|---|---|---|
| Mean Change in Schirmer's Test From Baseline to 28 Days | 10.5 (7.4 to 13.5) | 5.7 (1.4 to 9.9) |
Collected over Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | 0/34 (0%) | 0/34 (0%) | 33/34 (97.1%) |
| Placebo | 0/19 (0%) | 0/19 (0%) | 11/19 (57.9%) |
| Event | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo |
|---|---|---|
| SneezingRespiratory, thoracic and mediastinal disorders | 22/34 | 2/19 |
| Dysaesthesia pharynxRespiratory, thoracic and mediastinal disorders | 3/34 | 9/19 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/34 | 1/19 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 7/34 | 0/19 |
| Instillation site irritationGeneral disorders | 4/34 | 0/19 |
| Vision blurredEye disorders | 0/34 | 2/19 |
| Visual acuity reducedEye disorders | 3/34 | 0/19 |
| RhinorrheaRespiratory, thoracic and mediastinal disorders | 2/34 | 0/19 |
| Eye irritationEye disorders | 0/34 | 1/19 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 0/34 | 1/19 |
Subjects in the ITT population
| Age, Continuous(years) | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo | Total |
|---|---|---|---|
| Mean | 63.2 ± 13.5 | 64.7 ± 11.5 | 63.7 ± 12.7 |
| Sex: Female, Male(Participants) | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo | Total |
|---|---|---|---|
| Female | 27 | 15 | 42 |
| Male | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo | Total |
|---|---|---|---|
| Asian | 1 | 0 | 1 |
| Black/African American | 4 | 0 | 4 |
| White | 29 | 19 | 48 |
| Not Hispanic/Latino | 31 | 18 | 49 |
| Hispanic/Latino | 3 | 1 | 4 |
| Region of Enrollment(participants) | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo | Total |
|---|---|---|---|
| United States | 34 | 19 | 53 |
| Schirmer's Test(mm) | OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml | Placebo | Total |
|---|---|---|---|
| Mean | 6.3 ± 3.1 | 5.1 ± 3.1 | 5.9 ± 3.1 |
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Oyster Point Pharma, Inc.