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Nicotinic Acetylcholine Receptor Agonist

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

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

Study Summary

This trial will look at whether OC-01, a varenicline nasal spray, is effective and safe in treating dry eye symptoms in people who have had LASIK surgery.

Eligible Conditions

Dry Eye Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84 (3-months) postoperative and day 168 (6-months) postoperative lasik

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

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

Primary outcome measures

Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp

Secondary outcome measures

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

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?

Vance Thompson Vision NDLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential side effects of OC-01 (varenicline 0.6mg/ml) nasal spray?

"The safety of OC-01 (varenicline 0.6mg/ml) nasal spray was given a score of 3. This assessment was made because OC-01 is in Phase 3 clinical trials. This suggests that not only is there some data affirming its efficacy, but there are also multiple rounds of data attesting to its safety."

Answered by AI

How many people have signed up to participate in this clinical trial?

"Recruitment for this trial is currently on pause. The study was first posted on October 15th, 2021 and was last updated a little over a week ago on October 5th. If you're interested in participating in other studies, there are 142 clinical trials searching for patients with dry eye syndromes and 28 studies for OC-01 (varenicline 0.6mg/ml) nasal spray that are actively recruiting."

Answered by AI

What are the most notable findings from other research on OC-01 (varenicline 0.6mg/ml) nasal spray?

"Currently, there are a total of 28 clinical trials for OC-01 (varenicline 0.6mg/ml) nasal spray. 4 of those trials are in the final stage, Phase 3. Although the majority of research is based in Charleston, South carolina, there are 71 locations running clinical trials for OC-01 (varenicline 0.6mg/ml) nasal spray."

Answered by AI

Are there any more spots available for volunteers in this experiment?

"Unfortunately, this study is no longer recruiting patients. If you're looking for other trials, there are 142 trials for dry eye syndromes and 28 trials for OC-01 (varenicline 0.6mg/ml) nasal spray that are still recruiting."

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 Laser-assisted in Situ Keratomileusis (LASIK)

2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082974.