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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
Drug Has Already Been Approved
Pivotal Trial

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~19 spots leftby Nov 2025
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