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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01547936

Enrollment

Registered

2012-03-08

Start date

2012-02-29

Completion date

2012-02-29

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years of age & either sex, any race * Willing and able to follow all instructions * Positive history of dry eye disease * Use or desire to use drops for dry eye within the past 6 months

Exclusion criteria

* Have planned surgery during trial period * Female currently pregnant, planning a pregnancy or lactating * Use of disallowed medications * Have ocular infections, or ocular conditions that could affect study parameters * Have used an investigational drug or device within 30 days of start of study * Female that is currently pregnant, planning a pregnancy or lactating

Design outcomes

Primary

Measure	Time frame
change in tear film break up area	change from baseline in tear film break up area at 30 minutes post-CAE at study visit

Secondary

Measure	Time frame
change in Fluorescein Staining	change from baseline in staining at 30 minutes post-CAE
Change in Tear film break up time (TFBUT)	change from baseline in tear film break up time at 30 minutes post-CAE
Change in Conjunctival Redness	change from baseline in conjunctival redness at 30 minutes post-CAE

Countries

United States

Outcome results