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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease (DED)

In brief

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.

Key facts

Study ID

NCT04036292

Run by

Oyster Point Pharma, Inc.

People needed

758

Starts

2019-07-23

Expected to finish

2021-02-05

Last updated by the study team

2021-11-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

You may not qualify if…

• Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial 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.

Where it is running

• Cranberry Township — Cranberry Township, Pennsylvania, United States
• Warwick — Warwick, Rhode Island, United States
• Sioux Falls — Sioux Falls, South Dakota, United States
• Nashville — Nashville, Tennessee, United States
• Austin — Austin, Texas, United States
• Houston — Houston, Texas, United States
• San Antonio — San Antonio, Texas, United States
• San Antonio — San Antonio, Texas, United States
• Layton — Layton, Utah, United States
• Lynchburg — Lynchburg, Virginia, United States
• Phoenix — Phoenix, Arizona, United States
• New Port Beach — Newport Beach, California, United States
• Fort Collins — Fort Collins, Colorado, United States
• Waterbury — Waterbury, Connecticut, United States
• Delray Beach — Delray Beach, Florida, United States
• Indianapolis — Indianapolis, Indiana, United States
• Louisville — Louisville, Kentucky, United States
• Raynham — Raynham, Massachusetts, United States
• Las Vegas — Las Vegas, Nevada, United States
• Raleigh — Raleigh, North Carolina, United States
• Shelby — Shelby, North Carolina, United States
• Fargo — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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