NCT00569777

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

A Multi-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: 310 (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	K-Lens (generic name not established) and Ketotifen	combination drug-device product: contact lens (device) and anti-allergy drug
DEVICE	Placebo Lens	contact lens without drug

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2007-12-07
• Last updated: 2015-03-06
• Results posted: 2010-11-23

Locations

3 sites across 1 country: United States