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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glycerin 0.7%/PEG 400 0.3%
polyethylene glycol 400 0.4%/propylene glycol 0.3%
Sponsored by
Calm Water Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring Corneal Epitheliopathy, Tear Film Stability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Andover Research Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glycerin 0.7%/PEG 400 0.3%

polyethylene glycol 400 0.4%/propylene glycol 0.3%

Arm Description

20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days.

10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days.

Outcomes

Primary Outcome Measures

Tear Film Break-up Time
State-of-the-art methodology to assess tear stability.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2022
Last Updated
September 4, 2023
Sponsor
Calm Water Therapeutics LLC
Collaborators
Andover Research Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05660681
Brief Title
Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calm Water Therapeutics LLC
Collaborators
Andover Research Eye Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Corneal Epitheliopathy, Tear Film Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-masked, single-center, interventional trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glycerin 0.7%/PEG 400 0.3%
Arm Type
Experimental
Arm Description
20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days.
Arm Title
polyethylene glycol 400 0.4%/propylene glycol 0.3%
Arm Type
Active Comparator
Arm Description
10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days.
Intervention Type
Drug
Intervention Name(s)
glycerin 0.7%/PEG 400 0.3%
Other Intervention Name(s)
CWT-f-002
Intervention Description
Eye drop with active agents from the OTC Monograph.
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol 400 0.4%/propylene glycol 0.3%
Other Intervention Name(s)
Systane (R)
Intervention Description
Eye drop with active agents from the OTC Monograph.
Primary Outcome Measure Information:
Title
Tear Film Break-up Time
Description
State-of-the-art methodology to assess tear stability.
Time Frame
15 minutes after eye drop instillation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Gomes, MS
Organizational Affiliation
Andover Research Eye Institute
Official's Role
Study Director
Facility Information:
Facility Name
Andover Research Eye Institute
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28736335
Citation
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Results Reference
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PubMed Identifier
28705660
Citation
Farrand KF, Fridman M, Stillman IO, Schaumberg DA. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. 2017 Oct;182:90-98. doi: 10.1016/j.ajo.2017.06.033. Epub 2017 Jul 10.
Results Reference
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PubMed Identifier
22554205
Citation
Gensheimer WG, Kleinman DM, Gonzalez MO, Sobti D, Cooper ER, Smits G, Loxley A, Mitchnick M, Aquavella JV. Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops. J Ocul Pharmacol Ther. 2012 Oct;28(5):473-8. doi: 10.1089/jop.2011.0053. Epub 2012 May 3.
Results Reference
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Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops

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