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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636061
Recruitment Status : Completed
First Posted : August 17, 2018
Results First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: OC-01 (varenicline) nasal spray Drug: Placebo (vehicle) nasal spray Phase 2

Detailed Description:
This was a Phase 2b, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 01 nasal spray in adult subjects with DED. The study randomized 182 subjects, at least 22 years of age, who had a physician's diagnosis of dry eye disease and met all other study eligibility criteria to receive an application of OC-01 or placebo twice daily (BID) for 4 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: OC-01 Low Dose, 0.12 mg/mL
OC-01 (varenicline) nasal spray, Low Dose, 0.12 mg/mL
Drug: OC-01 (varenicline) nasal spray
OC-01 (varenicline) nasal spray

Active Comparator: OC-01 Mid Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray Mid dose, 0.6 mg/mL
Drug: OC-01 (varenicline) nasal spray
OC-01 (varenicline) nasal spray

Active Comparator: OC-01 High Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray High dose, 1.2 mg/mL
Drug: OC-01 (varenicline) nasal spray
OC-01 (varenicline) nasal spray

Placebo Comparator: Placebo
Placebo (vehicle) nasal spray
Drug: Placebo (vehicle) nasal spray
Placebo




Primary Outcome Measures :
  1. Mean Change in Schirmer's Test Score From Baseline to 28 Days [ Time Frame: 28 Days [Visit 1 (baseline) and Visit 5 (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-01. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.


Secondary Outcome Measures :
  1. Change From Baseline in Eye Dryness Score From Baseline to Day 28 [ Time Frame: 28 days [Visit 1 (baseline and Visit 5 (28 days)] ]
    Change in Eye Dryness Score from baseline to 28 days. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.

  2. Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE. [ Time Frame: 21 days [Visit 1 (baseline) and Visit 4 (21 days)] ]
    Change from baseline to Day 21 in Eye Dryness Score at 5 minutes post treatment in the CAE. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636061


Locations
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United States, California
Newport Beach
Newport Beach, California, United States, 92663
United States, Indiana
Indianapolis
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Andover
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Oyster Point Pharma, Inc.
  Study Documents (Full-Text)

Documents provided by Oyster Point Pharma, Inc.:
Study Protocol  [PDF] July 11, 2018
Statistical Analysis Plan  [PDF] October 4, 2018

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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03636061    
Other Study ID Numbers: OPP-002
First Posted: August 17, 2018    Key Record Dates
Results First Posted: October 25, 2021
Last Update Posted: October 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs