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Nicotinic Acetylcholine Receptor Agonist

Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)

Phase 3
Waitlist Available
Led By Brandon Baartman, MD
Research Sponsored by Brandon Baartman
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 from 2 days (48hours) post op to 7 days (1 week) post op
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved

Summary

This trial is testing a nasal spray to help patients who have dry eyes after PRK surgery. The spray works by stimulating nasal nerves to produce more tears. It has been recently approved as a preservative-free nasal spray for treating dry eye disease.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 2 days (48hours) post op to 7 days (1 week) post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 2 days (48hours) post op to 7 days (1 week) post op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Change in corneal epithelial healing

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OC-01 (varenicline 0.6mg/ml) nasal sprayExperimental Treatment1 Intervention
Group II: Placebo (vehicle) nasal sprayPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
FDA approved

Find a Location

Who is running the clinical trial?

Brandon BaartmanLead Sponsor
Brandon Baartman, MDPrincipal InvestigatorVance Thompson Vision
~14 spots leftby Dec 2025
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