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NCT04036292 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Dry Eye Disease (DED), sponsored by Oyster Point Pharma.

Completed
Registry status
Phase 3
Development phase
758
Enrollment target
20
Study locations

NCT04036292 is a Phase 3 study of Dry Eye Disease (DED) that has completed, run by Oyster Point Pharma. The registered enrollment target is 758 participants, above the 239-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (217% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT04036292, a Phase 3 study of Dry Eye Disease (DED), has completed, sponsored by Oyster Point Pharma.

COMPLETED
Registry status
Phase 3
Development phase
758 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Interventions

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

Study Locations (20)

Texas

  • Austin - Austin
  • Houston - Houston
  • San Antonio - San Antonio
  • San Antonio - San Antonio

North Carolina

  • Raleigh - Raleigh
  • Shelby - Shelby

Arizona

  • Phoenix - Phoenix

California

  • New Port Beach - Newport Beach

Colorado

  • Fort Collins - Fort Collins

Connecticut

  • Waterbury - Waterbury

Florida

  • Delray Beach - Delray Beach

Indiana

  • Indianapolis - Indianapolis

Trial Details

FieldValue
Enrollment Target 758 participants
Start Date 2019-07-23
Est. Completion 2021-02-05
Phase Phase 3

Sponsor

Oyster Point Pharma

10 total trials

What the Registry Record Tells You About NCT04036292

The ClinicalTrials.gov registry entry for NCT04036292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 758 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 239-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (217% higher). The listed sponsor is Oyster Point Pharma, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dry Eye Disease (DED) appearing as the primary indexed condition, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.

NCT04036292 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Texas, North Carolina, Arizona.

Frequently Asked Questions

What is clinical trial NCT04036292 about?

NCT04036292 is a clinical study titled "Evaluation of the Efficacy and Safety 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 NCT04036292?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 758 participants. The study started on 2019-07-23. Estimated completion is 2021-02-05.

What conditions does trial NCT04036292 study?

This clinical trial studies the following conditions: Dry Eye Disease (DED).

What interventions are being tested in trial NCT04036292?

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

Who is sponsoring clinical trial NCT04036292?

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

Where is trial NCT04036292 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Dry Eye Disease (DED)

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.