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

• ClinicalTrials.gov Identifier: NCT03873246
• Recruitment Status: Completed
• First Posted: March 13, 2019
• Results First Posted: June 8, 2022
• Last Update Posted: June 8, 2022
• Sponsor: Oyster Point Pharma, Inc.
• Information provided by (Responsible Party): Oyster Point Pharma, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Dry Eye Disease	Drug: OC-01 0.1% 0.6 mg/ml; Drug: OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); Other: placebo comparator	Phase 2

Detailed Description:

Study OPP-004 was a Phase 2, single-center, randomized, masked (including subjects, Investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in adult subjects with DED. The study planned to randomize approximately 120 subjects at least 22 years of age with a physicians' diagnosis of Dry Eye Disease and meeting all other study eligibility criteria to receive an application of OC-01 or placebo BID for 12 weeks. Subjects who terminated early during the application period were asked to complete safety assessments (if the subjects agree) prior to study exit. Subjects who were terminated early from the study were not replaced.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Controlled, Single-Masked Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
• Actual Study Start Date: February 18, 2019
• Actual Primary Completion Date: January 7, 2020
• Actual Study Completion Date: January 7, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: OC-01 0.1%, 0.6 mg/ml; OC-01 (varenicline) nasal spray, 0.6 mg/mL	Drug: OC-01 0.1% 0.6 mg/ml; OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml); Other Name: varenicline
Active Comparator: OC-01 0.2%, 1.2 mg/ml; OC-01 (varenicline) nasal spray, 1.2 mg/mL	Drug: OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); Other Name: varenicline
Placebo Comparator: Placebo; vehicle control	Other: placebo comparator; vehicle control

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Schirmer's Test Score From Baseline to 84 Days [ Time Frame: Visit 1 (baseline) and Visit 6 (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.

Other Outcome Measures:

1. Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 6 (Day 84) [ Time Frame: Visit 1 (baseline) and Visit 6 (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.
2. Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28) [ Time Frame: Visit 1 (baseline) and Visit 4 (28 Days) ]
   The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and the 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.
3. Mean Change in Schirmer's Test Score From Baseline to 84 Days (Visit 6) - Fellow Eye [ Time Frame: Visit 1 (baseline) to Visit 6 (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.
4. Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Study Eye [ Time Frame: Visit 1 (baseline) to Visit 4 (28 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 of OC-01 or placebo. Schirmer's test scores range from 0-35 mm where a higher score is indicative of a better outcome.
5. Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Fellow Eye [ Time Frame: Visit 1 (baseline) to Visit 4 (28 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.
6. Mean Change in Total Corneal Fluorescein Staining [ Time Frame: Visit 1 (baseline) and Visit 5 (56 days) ]
   A standardized grading system of 0-3 is used for each of the five areas of the cornea (inferior, superior, nasal, temporal, central). Grade 0 will be specified when no staining is present. The total score ranges from 0-15. Lower scores indicate improvement.

Eligibility Criteria

• 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 us 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 (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

Contacts and Locations

Locations

Mexico

Mexico City

Mexico City, Mexico

Sponsors and Collaborators

Oyster Point Pharma, Inc.

  Study Documents (Full-Text)

Documents provided by Oyster Point Pharma, Inc.:

Study Protocol  [PDF] March 7, 2019

Statistical Analysis Plan  [PDF] December 23, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Oyster Point Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT03873246
• Other Study ID Numbers: OPP-004
• First Posted: March 13, 2019
• Results First Posted: June 8, 2022
• Last Update Posted: June 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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