Trial · NCT03633461

Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

NCT03633461, Phase 2, Completed, Oyster Point Pharma, Inc.; results first posted 2022-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study). Trials, record NCT03633461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03633461

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)
NCT number: NCT03633461
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: Oyster Point Pharma, Inc.
Conditions: Dry Eye Disease
Interventions: OC-02 (simpinicline) nasal spray, Placebo (vehicle) nasal spray
First posted: 2018-08-16
Last updated: 2022-03-09
Results first posted: 2022-02-03

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Schirmer's Test From Baseline to 28 Days	28 days [Visit 1 (baseline) and Visit 5 (28 Days)]	Subjects in the ITT population	mm	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change in Schirmer's Test From Baseline to 28 Days	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml		10.5	95% Confidence Interval 7.4 to 13.5	mm
Mean Change in Schirmer's Test From Baseline to 28 Days	Placebo		5.7	95% Confidence Interval 1.4 to 9.9	mm

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	34
Overall Study	STARTED	Placebo	19
Overall Study	COMPLETED	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	34
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Visual acuity reduced	Eye disorders	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	3	34
other	Visual acuity reduced	Eye disorders	Placebo	0	19
other	Vision blurred	Eye disorders	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	0	34
other	Vision blurred	Eye disorders	Placebo	2	19
other	Eye irritation	Eye disorders	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	0	34
other	Eye irritation	Eye disorders	Placebo	1	19
other	Sneezing	Respiratory, thoracic and mediastinal disorders	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	22	34
other	Sneezing	Respiratory, thoracic and mediastinal disorders	Placebo	2	19
other	Throat irritation	Respiratory, thoracic and mediastinal disorders	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	7	34
other	Throat irritation	Respiratory, thoracic and mediastinal disorders	Placebo	0	19

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	0	34
Total, all-cause mortality	Placebo	0	19
Total, other adverse events	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	33	34
Total, other adverse events	Placebo	11	19
Total, serious adverse events	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml	0	34
Total, serious adverse events	Placebo	0	19

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml vs Placebo: deaths from any cause	Trial comparisons
OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03633461

GET https://conductscience.org/api/trials/v1/NCT03633461/events?page=2

API reference For AI assistants