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

NCT03636061 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OPP-002
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change in Schirmer's Test Score From Baseline to 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.

  28 Days [Visit 1 (baseline) and Visit 5 (28 days)]

Secondary Outcomes (2)

• Change From Baseline in Eye Dryness Score From Baseline to Day 28

  28 days [Visit 1 (baseline and Visit 5 (28 days)]

• Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE.

  21 days [Visit 1 (baseline) and Visit 4 (21 days)]

Study Arms (4)

OC-01 Low Dose, 0.12 mg/mL

ACTIVE COMPARATOR

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

Drug: OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mL

ACTIVE COMPARATOR

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

Drug: OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL

ACTIVE COMPARATOR

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

Drug: OC-01 (varenicline) nasal spray

Placebo

PLACEBO COMPARATOR

Placebo (vehicle) nasal spray

Drug: Placebo (vehicle) nasal spray

Interventions

OC-01 (varenicline) nasal spray DRUG

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL; OC-01 Low Dose, 0.12 mg/mL; OC-01 Mid Dose, 0.6 mg/mL

Placebo (vehicle) nasal spray DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oyster Point Pharma, Inc.: lead

Study Sites (3)

Newport Beach

Newport Beach, California, 92663, United States

Location

Indianapolis

Indianapolis, Indiana, 46290, United States

Location

Andover

Andover, Massachusetts, 01810, United States

Location

Related Publications (4)

• 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.

  PMID: 37096956 DERIVED

• 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.

  PMID: 36728653 DERIVED

• 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.

  PMID: 36401081 DERIVED

• 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.

  PMID: 36107843 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Varenicline; Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeffrey Nau
• Organization: Oyster Point Pharma, Inc.

jnau@oysterpointrx.com

609-382-9035

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: August 15, 2018
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)