Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops

• Status: Enrolling by invitation
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calm Water Therapeutics LLC
• Collaborator: Andover Research Eye Institute
• Treatments: Glycerol

Criteria

Inclusion Criteria:

• Be at least 18 years of age

• Have a reported history of dry eye for at least 6 months

• Have a Tear Film Breakup Time (TFBUT) measurement of >1 and <7 seconds at Visit 1

Exclusion Criteria:

• Known contraindications or sensitivities to the use of the study treatment or any of its components

• Have a clinically significant slit lamp finding at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters

• Have a condition (ocular or systemic) that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial