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Nicotinic Acetylcholine Receptor Partial Agonist

OC-01 (varenicline 0.6mg/ml) Nasal Spray for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Center for Ophthalmic and Vision Research, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of a new nasal spray medication to a placebo in reducing the symptoms of dry eye disease in people who wear soft contact lenses.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CLDEQ-8 scores at 4 weeks
Contact lens wear time at 4 weeks
Secondary outcome measures
Automated tear breakup time
CLDEQ-8 scores at 8 weeks
Contact lens wear time at 8 weeks
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OC-01 (varenicline 0.6mg/ml) nasal sprayExperimental Treatment1 Intervention
Intranasal delivery of OC-01 nasal spray twice daily (BID)
Group II: Placebo (vehicle) nasal sprayPlacebo Group1 Intervention
Intranasal delivery of placebo vehicle nasal spray twice daily (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OC-01 (varenicline 0.6mg/ml) Nasal Spray
2021
Completed Phase 4
~80

Find a Location

Who is running the clinical trial?

Center for Ophthalmic and Vision Research, LLCLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers
2021. "OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161208.
~22 spots leftby May 2025
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