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

NCT ID: NCT04036292

Last Updated: 2021-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

758 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-23

Study Completion Date

2021-02-05

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 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

Conditions

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Dry Eye Disease (DED)

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, 0.6 mg/mL

OC-01 (varenicline) nasal spray, 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, 1.2 mg/ML

Group Type ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray

Intervention Type DRUG

OC-01 (varenicline) nasal spray

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Group Type PLACEBO_COMPARATOR

Placebo (vehicle) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Interventions

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OC-01 (varenicline) nasal spray

OC-01 (varenicline) nasal spray

Intervention Type DRUG

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

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) 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.
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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Phoenix

Phoenix, Arizona, United States

Site Status

New Port Beach

Newport Beach, California, United States

Site Status

Fort Collins

Fort Collins, Colorado, United States

Site Status

Waterbury

Waterbury, Connecticut, United States

Site Status

Delray Beach

Delray Beach, Florida, United States

Site Status

Indianapolis

Indianapolis, Indiana, United States

Site Status

Louisville

Louisville, Kentucky, United States

Site Status

Raynham

Raynham, Massachusetts, United States

Site Status

Las Vegas

Las Vegas, Nevada, United States

Site Status

Raleigh

Raleigh, North Carolina, United States

Site Status

Shelby

Shelby, North Carolina, United States

Site Status

Fargo

Fargo, North Dakota, United States

Site Status

Cranberry Township

Cranberry Township, Pennsylvania, United States

Site Status

Warwick

Warwick, Rhode Island, United States

Site Status

Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Nashville

Nashville, Tennessee, United States

Site Status

Austin

Austin, Texas, United States

Site Status

Houston

Houston, Texas, United States

Site Status

San Antonio

San Antonio, Texas, United States

Site Status

San Antonio

San Antonio, Texas, United States

Site Status

Layton

Layton, Utah, United States

Site Status

Lynchburg

Lynchburg, Virginia, 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)

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, Vollmer P, Paauw J, Chiu KH, Henry E, Striffler K, Nau J; ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. Ophthalmology. 2022 Apr;129(4):379-387. doi: 10.1016/j.ophtha.2021.11.004. Epub 2021 Nov 10.

Reference Type DERIVED
PMID: 34767866 (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-101

Identifier Type: -

Identifier Source: org_study_id