Dry Eye Disease
Conditions
Keywords
Corneal Epitheliopathy, Tear Film Stability
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.
Interventions
DRUGglycerin 0.7%/PEG 400 0.3%
Eye drop with active agents from the OTC Monograph.
DRUGpolyethylene glycol 400 0.4%/propylene glycol 0.3%
Eye drop with active agents from the OTC Monograph.
Sponsors
Andover Research Eye Institute
Calm Water Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-masked, single-center, interventional trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break-up Time | 15 minutes after eye drop instillation | State-of-the-art methodology to assess tear stability. |
Countries
United States
Outcome results
None listed