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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: glycerin 0.7%/PEG 400 0.3%; Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%

• Registration Number: NCT05660681
• Lead Sponsor: Calm Water Therapeutics LLC

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-23
• Study Start: 2022-12-12
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-21
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glycerin 0.7%/PEG 400 0.3%	glycerin 0.7%/PEG 400 0.3%	20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days.
polyethylene glycol 400 0.4%/propylene glycol 0.3%	polyethylene glycol 400 0.4%/propylene glycol 0.3%	10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days.

Primary Outcome Measures

Name	Time	Method
Tear Film Break-up Time	15 minutes after eye drop instillation	State-of-the-art methodology to assess tear stability.

Trial Locations

Locations (1)

Andover Research Eye Institute; 🇺🇸 Andover, Massachusetts, United States