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

NCT ID: NCT03636061

Last Updated: 2021-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2018-09-26

Brief Summary

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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

Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OC-01 Low Dose, 0.12 mg/mL

OC-01 (varenicline) nasal spray, Low Dose, 0.12 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mL

OC-01 (varenicline) nasal spray Mid dose, 0.6 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL

OC-01 (varenicline) nasal spray High dose, 1.2 mg/mL

Group Type ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 (varenicline) nasal spray

Placebo

Placebo (vehicle) nasal spray

Group Type PLACEBO_COMPARATOR

Placebo (vehicle) nasal spray

Intervention Type DRUG

Placebo

Interventions

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OC-01 (varenicline) nasal spray

OC-01 (varenicline) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oyster Point Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Newport Beach

Newport Beach, California, United States

Site Status

Indianapolis

Indianapolis, Indiana, United States

Site Status

Andover

Andover, Massachusetts, United States

Site Status

Countries

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United States

References

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Hauswirth SG, Kabat AG, Hemphill M, Somaiya K, Hendrix LH, Gibson AA. Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease. J Comp Eff Res. 2023 Jun;12(6):e220215. doi: 10.57264/cer-2022-0215. Epub 2023 Apr 25.

Reference Type DERIVED
PMID: 37096956 (View on PubMed)

Sheppard JD, O'Dell LE, Karpecki PM, Raizman MB, Whitley WO, Blemker G, Hemphill M, Hendrix LH, Gibson A, Macsai M. Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes? Optom Vis Sci. 2023 Feb 1;100(2):164-169. doi: 10.1097/OPX.0000000000001986. Epub 2022 Dec 31.

Reference Type DERIVED
PMID: 36728653 (View on PubMed)

Nijm LM, Zhu D, Hemphill M, Blemker GL, Hendrix LH, Kabat AG, Gibson AA. Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials. Ophthalmol Ther. 2023 Feb;12(1):355-364. doi: 10.1007/s40123-022-00607-7. Epub 2022 Nov 18.

Reference Type DERIVED
PMID: 36401081 (View on PubMed)

Wirta D, Torkildsen GL, Boehmer B, Hollander DA, Bendert E, Zeng L, Ackermann M, Nau J. ONSET-1 Phase 2b Randomized Trial to Evaluate the Safety and Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease. Cornea. 2022 Oct 1;41(10):1207-1216. doi: 10.1097/ICO.0000000000002941. Epub 2021 Dec 21.

Reference Type DERIVED
PMID: 36107843 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OPP-002

Identifier Type: -

Identifier Source: org_study_id