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

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ClinicalTrials.gov Identifier: NCT04036292
Recruitment Status : Completed
First Posted : July 29, 2019
Results First Posted : November 22, 2021
Last Update Posted : November 22, 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 (DED) Drug: OC-01 (varenicline) nasal spray Drug: Placebo (vehicle) nasal spray Phase 3

Detailed Description:
This was a Phase 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 758 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 and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : February 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: OC-01 Low Dose, 0.6 mg/mL
OC-01 (varenicline) nasal spray, 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, 1.2 mg/ML
Drug: OC-01 (varenicline) nasal spray
OC-01 (varenicline) nasal spray

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




Primary Outcome Measures :
  1. Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28) [ Time Frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)] ]
    The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes [ Time Frame: 28 Days [Visit 1 (baseline) and Visit 4a (28 days)] ]
    Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.

  2. Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28 [ Time Frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)] ]
    Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.

  3. Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28 [ Time Frame: 28 Days [Visit 1 (baseline) and Visit 4b (28 days)] ]
    Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.

  4. Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2 [ Time Frame: 14 Days [Visit 1 (baseline) and Visit 3 (14 days)] ]
    Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.

  5. Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1 [ Time Frame: 7 Days [Visit 1 (baseline) and Visit 2 (7 days)] ]
    Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.



Information from the National Library of Medicine

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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) 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.

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): NCT04036292


Locations
Show Show 22 study locations
Sponsors and Collaborators
Oyster Point Pharma, Inc.
  Study Documents (Full-Text)

Documents provided by Oyster Point Pharma, Inc.:
Study Protocol  [PDF] September 18, 2019
Statistical Analysis Plan  [PDF] April 29, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04036292    
Other Study ID Numbers: OPP-101
First Posted: July 29, 2019    Key Record Dates
Results First Posted: November 22, 2021
Last Update Posted: November 22, 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