NCT03994406

Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Glia, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.

Detailed description

The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.

Conditions

• Contact Lens Discomfort
• Contact Lens-induced Corneal Disorder
• Contact Lens Acute Red Eye
• Contact Lens-induced Corneal Fluorescein Staining

Interventions

Type	Name	Description
DRUG	CLM2 topical gel	Active topical gel for forehead dermal application
DRUG	Placebo topical gel	Placebo topical gel for forehead dermal application

Timeline

• Start date: 2019-06-27
• Primary completion: 2019-08-30
• Completion: 2019-10-30
• First posted: 2019-06-21
• Last updated: 2023-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study