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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

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.

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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


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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873246


Locations
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03873246    
Other Study ID Numbers: OPP-004
First Posted: March 13, 2019    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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