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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 Laser-assisted in Situ Keratomileusis (LASIK)

Phase 3
Waitlist Available
Research Sponsored by Vance Thompson Vision ND
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 day 84 (3-months) postoperative and day 168 (6-months) postoperative lasik
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

This trial is testing a nasal spray to see if it can safely and effectively reduce dry eye symptoms in people who have had LASIK surgery. The spray works by helping the eyes produce more tears, which can ease dryness and discomfort.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84 (3-months) postoperative and day 168 (6-months) postoperative lasik
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 (3-months) postoperative and day 168 (6-months) postoperative lasik for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp
Secondary study objectives
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Change in tear collection lab values
Incidence and severity of adverse events
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.

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?

Vance Thompson Vision NDLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
~10 spots leftby Dec 2025
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