Varenicline solution for Dry Eye Syndromes

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Stephenson Eye Associates, Venice, FL
Dry Eye Syndromes+3 More
Varenicline solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.

Eligible Conditions

  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Day 1/Day 28

28 days
AEs
Day 1
Surface qualifier image change
Day 1/Day 28
Exploratory analysis of change in Cassini
Day 21
QoL
Day 28
Change from baseline in surface qualifier image analysis
Corneal fluorescein staining score
EDS
IOP
TBUT
Tear osmolarity
VA

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

OC-01 (varenicline solution) nasal spray 0.03 mg
1 of 2
Placebo nasal spray (OC-01 Vehicle Nasal Spray)
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Varenicline solution · Has Placebo Group · Phase 4

OC-01 (varenicline solution) nasal spray 0.03 mg
Drug
Experimental Group · 1 Intervention: Varenicline solution · Intervention Types: Drug
Placebo nasal spray (OC-01 Vehicle Nasal Spray)
Drug
PlaceboComparator Group · 1 Intervention: Placebo nasal spray (OC-01 Vehicle Nasal Spray) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1/day 28
Closest Location: Stephenson Eye Associates · Venice, FL
Photo of florida 1Photo of florida 2Photo of florida 3
2011First Recorded Clinical Trial
1 TrialsResearching Dry Eye Syndromes
1 CompletedClinical Trials

Who is running the clinical trial?

Stephenson Eye AssociatesLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 22 years of age at the screening visit.
You are willing and able to participate in all study assessments and visits.
You have sufficient hand strength to administer the study drug.
You have an OSDI score ≥ 13.
You have a positive abnormal Cassini surface qualifier test result.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.