NCT05660681

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

A Single-Center, Double-Masked, Randomized Study Evaluating the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops Compared to Systane® Preservative-Free Eye Drops in the Treatment of the Signs and Symptoms of Dry Eye Disease (DED)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Calm Water Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study CWT-f-002 lubricant eye drop is being evaluated in subjects with dry eye. This OTC eye drop has previously shown promising results in multiple preclinical and clinical settings. The active comparator for this study is Systane (R). Ingredient lists as follows. CWT-f-002: Active Ingredients are glycerin 0.7% and polyethylene glycol 400 0.4%. Inactive ingredients are mannitol, polylysine-graft-polyethylene glycol, sterile water for injection, and sodium phosphate buffer. Systane: Active ingredients are polyethylene glycol 400 0.4% and propylene glycol 0.3%. Inactive ingredients are boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. Systane (R) may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Both products are preservative free and supplied in unit dosers.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	glycerin 0.7%/PEG 400 0.3%	Eye drop with active agents from the OTC Monograph.
DRUG	polyethylene glycol 400 0.4%/propylene glycol 0.3%	Eye drop with active agents from the OTC Monograph.

Timeline

• Start date: 2022-12-12
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-12-21
• Last updated: 2023-09-06

Locations

1 site across 1 country: United States