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

Dry Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688802
• Other study ID #: OPP-005
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2021
• Source: Oyster Point Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Tufts	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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