NCT00889252

Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

A Single-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Vistakon Pharmaceuticals · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DEVICE	contact lens with ketotifen	K-Lens (generic name not established) and Ketotifen combination drug-device product
DEVICE	contact lens	Placebo contact lens

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• First posted: 2009-04-28
• Last updated: 2015-03-06
• Results posted: 2010-11-23

Locations

1 site across 1 country: United States