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

Phase 2

Completed

Conditions: Dry Eye Disease

Interventions: Drug: OC-01 (varenicline) nasal spray
Drug: Placebo (vehicle control) nasal spray

Registration Number: NCT03688802

Lead Sponsor: Oyster Point Pharma, Inc.

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OC-01 (varenicline) nasal spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, 1.2 mg/mL, one time dosing
Placebo (vehicle control) nasal spray	Placebo (vehicle control) nasal spray	Placebo (vehicle control) nasal spray, one time dosing

Primary Outcome Measures

Name	Time	Method
Mean Change in Goblet Cell Area	Baseline (pre-treatment), 1 day (post treatment)	Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.
Mean Change in Goblet Cell Perimeter	Baseline (pre-treatment), 1 day (post treatment)	Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.
Change in Meibomian Gland Area, Upper Lid	Baseline (pre-treatment), 1 day (post treatment)	Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome
Mean Change in Meibomian Gland Area, Lower Lid.	Baseline (pre-treatment), 1 day (post treatment)	Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.
Mean Change in Meibomian Gland Perimeter, Upper Lid.	Baseline (pre-treatment), 1 day (post treatment)	Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.
Mean Change in Meibomian Gland Perimeter, Lower Lid	Baseline (pre-treatment), 1 day (post treatment)	Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.