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CompletedNCT03633461Updated Mar 9, 2022Results posted

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

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

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
22 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

03

In context

Dry Eye Syndromes

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
53 participants (actual)

Study arms

  • Active comparator
    OC-02 (simpinicline) spray spray, 11.1 mg/ml

    OC-02 (simpinicline) nasal spray, 11.1 mg/ml

    Drug: OC-02 (simpinicline) nasal spray

  • Placebo comparator
    Placebo

    Placebo (vehicle) nasal spray

    Drug: Placebo (vehicle) nasal spray

Interventions

  • DrugOC-02 (simpinicline) nasal spray

    OC-02 (simpinicline) nasal spray, 11.1 mg/ml

    Also known as: OC-02 (simpinicline) nasal spray, 11.1 mg/ml

  • DrugPlacebo (vehicle) nasal spray

    Placebo (vehicle) nasal spray

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What researchers measure

Primary outcomes

  1. 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)]

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Results

Posted Feb 3, 2022

Participant flow

Participant flow — Overall Study
MilestoneOC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlacebo
Started3419
Completed3418
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryMean 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)]
Reported as:
Least squares mean · mm
Mean Change in Schirmer's Test From Baseline to 28 Days
mmOC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlacebo
Mean Change in Schirmer's Test From Baseline to 28 Days10.5 (7.4 to 13.5)5.7 (1.4 to 9.9)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml0/34 (0%)0/34 (0%)33/34 (97.1%)
Placebo0/19 (0%)0/19 (0%)11/19 (57.9%)
Most frequent other events
Showing 10 of 26
Most frequent other events
EventOC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlacebo
SneezingRespiratory, thoracic and mediastinal disorders22/342/19
Dysaesthesia pharynxRespiratory, thoracic and mediastinal disorders3/349/19
CoughRespiratory, thoracic and mediastinal disorders10/341/19
Throat irritationRespiratory, thoracic and mediastinal disorders7/340/19
Instillation site irritationGeneral disorders4/340/19
Vision blurredEye disorders0/342/19
Visual acuity reducedEye disorders3/340/19
RhinorrheaRespiratory, thoracic and mediastinal disorders2/340/19
Eye irritationEye disorders0/341/19
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/341/19

Baseline characteristics

Subjects in the ITT population

Age, Continuous
Age, Continuous(years)OC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlaceboTotal
Mean63.2 ± 13.564.7 ± 11.563.7 ± 12.7
Sex: Female, Male
Sex: Female, Male(Participants)OC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlaceboTotal
Female271542
Male7411
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)OC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlaceboTotal
Asian101
Black/African American404
White291948
Not Hispanic/Latino311849
Hispanic/Latino314
Region of Enrollment
Region of Enrollment(participants)OC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlaceboTotal
United States341953
Schirmer's Test
Schirmer's Test(mm)OC-02 (Simpinicline) Spray Spray, 11.1 mg/mlPlaceboTotal
Mean6.3 ± 3.15.1 ± 3.15.9 ± 3.1
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Study locations

2 sites
  • Louisville
    Louisville, Kentucky 40206, United States
  • Nashville
    Nashville, Tennessee 37205, United States
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References and documents

Study documents

  • Study protocol · Jul 11, 2018
  • Statistical analysis plan · Oct 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03633461
Lead sponsor
Oyster Point Pharma, Inc.
Responsible party
Sponsor
First posted
Aug 16, 2018
Start date
Aug 14, 2018
Primary completion
Sep 20, 2018
Completion
Sep 20, 2018
Results posted
Feb 3, 2022
Last update
Mar 9, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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