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OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers

NCT05161208 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-11-03

No results posted yet for this study

Summary

This study is a single center, prospective, randomized, controlled, double-masked, two-arm investigator-initiated study to investigate the efficacy of OC-01 (varenicline) nasal spray on the signs and symptoms of dry eye disease in daily soft contact lens wearers.

Conditions

  • Dry Eye

Interventions

DRUG

OC-01 (varenicline 0.6mg/ml) Nasal Spray

Intranasal delivery of OC-01 nasal spray twice daily (BID)

DRUG

Placebo (vehicle) nasal spray

Intranasal delivery of Placebo (vehicle) nasal spray twice daily (BID)

Sponsors & Collaborators

  • Center for Ophthalmic and Vision Research, LLC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-03
Primary Completion
2022-07-25
Completion
2022-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161208 on ClinicalTrials.gov