Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

NCT03873246 | Completed Phase 2 Results

• 1 other identifier: OPP-004
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change in Schirmer's Test Score From Baseline to 84 Days

  The Schirmer's test measures the amount of tears produced by numbing the eye and placing a paper strip in the eye for 5 minutes and distance of wetting was recorded following treatment with OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome.

  Visit 1 (baseline) and Visit 6 (84 days)

Other Outcomes (6)

• Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 6 (Day 84)

  Visit 1 (baseline) and Visit 6 (84 days)

• Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)

  Visit 1 (baseline) and Visit 4 (28 Days)

• Mean Change in Schirmer's Test Score From Baseline to 84 Days (Visit 6) - Fellow Eye

  Visit 1 (baseline) to Visit 6 (84 Days)

Study Arms (3)

OC-01 0.1%, 0.6 mg/ml

ACTIVE COMPARATOR

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

Drug: OC-01 0.1% 0.6 mg/ml

OC-01 0.2%, 1.2 mg/ml

ACTIVE COMPARATOR

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

Drug: OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

Placebo

PLACEBO COMPARATOR

vehicle control

Other: placebo comparator

Interventions

OC-01 0.1% 0.6 mg/ml DRUG

OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)

Also known as: varenicline

OC-01 0.1%, 0.6 mg/ml

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml) DRUG

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

Also known as: varenicline

OC-01 0.2%, 1.2 mg/ml

placebo comparator OTHER

vehicle control

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 us 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 (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 an 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 (1)

Mexico City

Mexico City, Mexico

Location

Related Publications (2)

• 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

• Quiroz-Mercado H, Hernandez-Quintela E, Chiu KH, Henry E, Nau JA. A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study. Ocul Surf. 2022 Apr;24:15-21. doi: 10.1016/j.jtos.2021.12.007. Epub 2021 Dec 15.

  PMID: 34920097 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: March 11, 2019
• First Posted: March 13, 2019
• Study Start: February 18, 2019
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)