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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-08-15

Brief Summary

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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.

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Detailed Description

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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

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

glycerin 0.7%/PEG 400 0.3%

Intervention Type DRUG

Eye drop with active agents from the OTC Monograph.

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.

Group Type ACTIVE_COMPARATOR

polyethylene glycol 400 0.4%/propylene glycol 0.3%

Intervention Type DRUG

Eye drop with active agents from the OTC Monograph.

Interventions

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glycerin 0.7%/PEG 400 0.3%

Eye drop with active agents from the OTC Monograph.

Intervention Type DRUG

polyethylene glycol 400 0.4%/propylene glycol 0.3%

Eye drop with active agents from the OTC Monograph.

Intervention Type DRUG

Other Intervention Names

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CWT-f-002 Systane (R)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No