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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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

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Keratoconjunctivitis Sicca

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tarek Shazly, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society