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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)

Primary Purpose

Dry Eye Disease

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

OC-01 0.1% 0.6 mg/ml

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

placebo comparator

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mexico City

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OC-01 0.1%, 0.6 mg/ml

OC-01 0.2%, 1.2 mg/ml

Placebo

Arm Description

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

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

vehicle control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03873246

First Posted

March 11, 2019

Last Updated

March 8, 2022

Sponsor

Oyster Point Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03873246

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 18, 2019 (Actual)

Primary Completion Date

January 7, 2020 (Actual)

Study Completion Date

January 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oyster Point Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OC-01 0.1%, 0.6 mg/ml

Arm Type

Active Comparator

Arm Description

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

Arm Title

OC-01 0.2%, 1.2 mg/ml

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

vehicle control

Intervention Type

Drug

Intervention Name(s)

OC-01 0.1% 0.6 mg/ml

Other Intervention Name(s)

varenicline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

varenicline

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

placebo comparator

Intervention Description

vehicle control

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Study Eye

Description

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.

Time Frame

Visit 1 (baseline) to Visit 4 (28 days)]

Title

Mean Change in Schirmer's Test Score From Baseline to 28 Days (Visit 4) - Fellow Eye

Description

Time Frame

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

Title

Mean Change in Total Corneal Fluorescein Staining

Description

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.

Time Frame

Visit 1 (baseline) and Visit 5 (56 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Mexico City

City

Mexico City

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34920097

Citation

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.

Results Reference

derived

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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)

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