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IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL

NCT05136924 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-30

No results posted yet for this 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)

Conditions

Interventions

DRUG

OC-01 (varenicline 1.2mg/ml) nasal spray vs Placebo

OC-01 nasal spray containing varenicline for treatment of signs and symptoms of DED. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production to bathe the corneal nerve endings in a protective layer of tear film. In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway VS Placebo

OTHER

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Sponsors & Collaborators

  • Vance Thompson Vision - MT

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136924 on ClinicalTrials.gov