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Cholinergic Agonist

OC-01 for Dry Eye Syndrome

Phase 2
Waitlist Available
Research Sponsored by Vance Thompson Vision - MT
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 baseline to day 0 (surgical day) and day 7 to day 28 (1-month postoperative cxl)
Awards & highlights

Study Summary

A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated study to Assess the Efficacy of OC-01 (varenicline) Nasal Spray on signs and symptoms of Dry Eye Disease in subjects following Corneal Collagen Crosslinking (CXL)

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 0 (surgical day) and day 7 to day 28 (1-month postoperative cxl)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 0 (surgical day) and day 7 to day 28 (1-month postoperative cxl) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corneal Epithelial Healing
NEI VFQ-25 Questionnaire
Secondary outcome measures
Adverse Events
Corneal Fluorescein Staining
Dryness Scoring
+1 more

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OC-01Experimental Treatment1 Intervention
(varenicline 1.2mg/ml) nasal spray
Group II: PlaceboPlacebo Group1 Intervention
(vehicle) nasal spray

Find a Location

Who is running the clinical trial?

Vance Thompson Vision - MTLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL
2021. "IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136924.
All > Chantix
~6 spots leftby Apr 2025
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