Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Description

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease (DED)

Study Start Date

February, 27 2018

Estimated Completion Date

June 2018

Interventions

  • Drug: OC-02
  • Drug: Placebos

Study ID

Oyster Point Pharma, Inc. -- OPP-001

Status

Unknown

Trial ID

NCT03452397

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

160

Sponsor

Oyster Point Pharma, Inc.

Inclusion Criteria

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

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 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 DED 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

Gender

All

Ages

22 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Andover - Andover, Massachusetts 19.9 miles Kristen Striffler None None

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