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

Sponsor

Calm Water Therapeutics LLC (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05660681

Collaborator

Andover Research Eye Institute (Industry)

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: glycerin 0.7%/PEG 400 0.3% Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-masked, single-center, interventional trialRandomized, double-masked, single-center, interventional trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Dec 12, 2022

Anticipated Primary Completion Date :

Feb 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: glycerin 0.7%/PEG 400 0.3% Eye drop with active agents from the OTC Monograph. Other Names: CWT-f-002
Active Comparator: 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.	Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3% Eye drop with active agents from the OTC Monograph. Other Names: Systane (R)

Arm

Intervention/Treatment

Experimental: 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.

Drug: glycerin 0.7%/PEG 400 0.3%

Eye drop with active agents from the OTC Monograph.

Other Names:

CWT-f-002

Active Comparator: 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.

Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%

Eye drop with active agents from the OTC Monograph.

Other Names:

Systane (R)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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