NCT01547936

Effect of Controlled Adverse Environment (CAE) on Tear Film Stability

A Single-Center Study Evaluating the Effect of the Controlled Adverse Environment (CAE) on Tear Film Stability Using the OPI 2.0 System, Ocular Protection Index (OPI), Tear Film Break-Up Time (TFBUT) and Mean Break up Area by Region (MBA) in Patients Diagnosed With Dry Eye Evaluated During Their Natural Blink Pattern

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.

Detailed description

Single-Center, Pilot, controlled adverse environment (CAE) Study. This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure. All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.

Conditions

• Keratoconjunctivitis Sicca

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-03-08
• Last updated: 2012-03-08

Locations

1 site across 1 country: United States