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

September 4, 2023 updated by: Calm Water Therapeutics LLC

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Research Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Film Break-up Time
Time Frame: 15 minutes after eye drop instillation
State-of-the-art methodology to assess tear stability.
15 minutes after eye drop instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calm Water Therapeutics LLC

Collaborators

Andover Research Eye Institute

Investigators

  • Study Director: Paul Gomes, MS, Andover Research Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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