Clinical trial NCT05660681: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Keywords: Corneal Epitheliopathy
Tear Film Stability
Lead sponsor: Calm Water Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Andover Research Eye Institute
First posted: 2022-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-masked, single-center, interventional trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tear Film Break-up Time
timeFrame: 15 minutes after eye drop instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Research Eye Institute
state: Massachusetts
Study officials:
affiliation: Andover Research Eye Institute
name: Paul Gomes, MS
role: STUDY_DIRECTOR
References:
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.
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.
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.