Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

• ClinicalTrials.gov Identifier: NCT03688802
• Recruitment Status: Completed
• First Posted: September 28, 2018
• Results First Posted: December 29, 2021
• Last Update Posted: December 29, 2021
• 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 safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Condition or disease	Intervention/treatment	Phase
Dry Eye Disease	Drug: OC-01 (varenicline) nasal spray; Drug: Placebo (vehicle control) nasal spray	Phase 2

Detailed Description:

This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)
• Actual Study Start Date: September 25, 2018
• Actual Primary Completion Date: September 30, 2019
• Actual Study Completion Date: September 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: OC-01 (varenicline) nasal spray, 1.2 mg/mL; OC-01 (varenicline) nasal spray, 1.2 mg/mL, one time dosing	Drug: OC-01 (varenicline) nasal spray; OC-01 (varenicline) nasal spray
Placebo Comparator: Placebo (vehicle control) nasal spray; Placebo (vehicle control) nasal spray, one time dosing	Drug: Placebo (vehicle control) nasal spray; Placebo

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Goblet Cell Area [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.
2. Mean Change in Goblet Cell Perimeter [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.
3. Change in Meibomian Gland Area, Upper Lid [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome
4. Mean Change in Meibomian Gland Area, Lower Lid. [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.
5. Mean Change in Meibomian Gland Perimeter, Upper Lid. [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.
6. Mean Change in Meibomian Gland Perimeter, Lower Lid [ Time Frame: Baseline (pre-treatment), 1 day (post treatment) ]
   Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Have used and/or desired to use 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 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

Contacts and Locations

Locations

United States, Massachusetts

Tufts

Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Oyster Point Pharma, Inc.

  Study Documents (Full-Text)

Documents provided by Oyster Point Pharma, Inc.:

Study Protocol  [PDF] March 26, 2019

Statistical Analysis Plan  [PDF] July 1, 2020

More Information

• Responsible Party: Oyster Point Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT03688802
• Other Study ID Numbers: OPP-005
• First Posted: September 28, 2018
• Results First Posted: December 29, 2021
• Last Update Posted: December 29, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Dry Eye Syndromes; Eye Diseases; Keratoconjunctivitis Sicca; 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