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Nicotinic Acetylcholine Receptor Agonist

OC-01 (varenicline 0.6mg/ml) nasal spray for Dry Eye Syndrome

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

Study Summary

This trial will test the safety and effectiveness of OC-01, a varenicline nasal spray, for treating dry eye in people who have had PRK surgery.

Eligible Conditions

Dry Eye Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 2 days (48hours) post op to 7 days (1 week) post op

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score

Change in corneal epithelial healing

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brandon BaartmanLead Sponsor

Brandon Baartman, MDPrincipal InvestigatorVance Thompson Vision

Frequently Asked Questions

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

How many subjects are being enrolled in this experiment?

"That is correct. The clinical trial in question, which was originally posted on 8/30/2021, is still recruiting patients. Recently, on 9/15/2021, the study updated its information to reflect that it is admitting 60 patients at 1 location."

Answered by AI

Is OC-01 (varenicline 0.6mg/ml) nasal spray a new medication?

"Varenicline 0.6mg/ml, or OC-01, is being researched in 28 different clinical trials at the moment, 4 of which are Phase 3 studies. Although a majority of the research for this nasal spray is conducted in Charleston, South carolina, there are 71 total locations running these investigations."

Answered by AI

Has OC-01 (varenicline 0.6mg/ml) nasal spray received FDA approval?

"OC-01 (varenicline 0.6mg/ml) nasal spray is considered safe, with a score of 3 on Power's safety scale. This is because Phase 3 trials have shown some evidence of efficacy, and there is supporting data from multiple rounds of testing."

Answered by AI

Are patients still being accepted into this clinical trial?

"The study, as indicated by clinicaltrials.gov, is still looking for volunteers. The original posting was on 8/30/2021 and the most recent update was 9/15/2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

Brandon Baartman 2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045508.

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