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NCT03636061 · ClinicalTrials.gov registry record · Phase 2

Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

A Phase 2 study, sponsored by Oyster Point Pharma.

Completed
Registry status
Phase 2
Development phase
182
Enrollment target

NCT03636061: Completed Phase 2 study, sponsored by Oyster Point Pharma.

NCT03636061 is a Phase 2 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 182 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03636061, a Phase 2 study, has completed, sponsored by Oyster Point Pharma.

COMPLETED
Registry status
Phase 2
Development phase
182 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease

Primary Outcome

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-01. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.

Interventions

  • DRUG Placebo (vehicle) nasal spray
  • DRUG OC-01 (varenicline) nasal spray

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2018-08-15
Est. Completion 2018-09-26
Phase Phase 2
Oyster Point Pharma

10 total trials

What the finished NCT03636061 record still lists

NCT03636061 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.

NCT03636061 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03636061 about?

NCT03636061 is a clinical study titled "Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease". The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease

What is the current status of trial NCT03636061?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2018-08-15. Estimated completion is 2018-09-26.

What interventions are being tested in trial NCT03636061?

The interventions under investigation include: Placebo (vehicle) nasal spray (DRUG), OC-01 (varenicline) nasal spray (DRUG).

Who is sponsoring clinical trial NCT03636061?

This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03636061's enrollment target sits among peer trials

182 363rd of 2000 higher than 1,636 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03636061, the US trial registry maintained by the National Library of Medicine. NCT03636061 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.