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

Dry Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660681
• Other study ID #: CWT-002
• Status: Completed
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: Calm Water Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• glycerin 0.7%/PEG 400 0.3%
Eye drop with active agents from the OTC Monograph.
• polyethylene glycol 400 0.4%/propylene glycol 0.3%
Eye drop with active agents from the OTC Monograph.

Locations

Country	Name	City	State
United States	Andover Research Eye Institute	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Calm Water Therapeutics LLC	Andover Research Eye Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Film Break-up Time	State-of-the-art methodology to assess tear stability.	15 minutes after eye drop instillation