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Phase 2 N=18 Randomized Double-blind Treatment

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

Dry Eye Disease

Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Mean Change in Goblet Cell Area — -38.8; -6.7 um

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
OC-01 (varenicline) nasal spray (Drug); Placebo (vehicle control) nasal spray (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oyster Point Pharma, Inc.
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change in Goblet Cell Area
-38.8; -6.7
PRIMARY
Mean Change in Goblet Cell Perimeter
-7.7; -1.8
PRIMARY
Change in Meibomian Gland Area, Upper Lid
11.2; -143.2
PRIMARY
Mean Change in Meibomian Gland Area, Lower Lid.
-29.9; -12.4
PRIMARY
Mean Change in Meibomian Gland Perimeter, Upper Lid.
6.15; -19.2
PRIMARY
Mean Change in Meibomian Gland Perimeter, Lower Lid
-4; 4.2

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03688802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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