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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
OC-01 (varenicline) nasal spray
Placebo
Tufts
Boston, Massachusetts, United States
Mean Change in Goblet Cell Area
Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.
Time frame: Baseline (pre-treatment), 1 day (post treatment)
Mean Change in Goblet Cell Perimeter
Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.
Time frame: Baseline (pre-treatment), 1 day (post treatment)
Change in Meibomian Gland Area, Upper Lid
Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome
Time frame: Baseline (pre-treatment), 1 day (post treatment)
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.
Time frame: Baseline (pre-treatment), 1 day (post treatment)
Mean Change in Meibomian Gland Perimeter, Upper Lid.
Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.
Time frame: Baseline (pre-treatment), 1 day (post treatment)
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.
Time frame: Baseline (pre-treatment), 1 day (post treatment)
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