Clinical trial NCT01547936: Effect of Controlled Adverse Environment (CAE) on Tear Film Stability
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with dry eye disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in tear film break up area
timeFrame: change from baseline in tear film break up area at 30 minutes post-CAE at study visit
Secondary outcomes:
measure: change in Fluorescein Staining
timeFrame: change from baseline in staining at 30 minutes post-CAE
measure: Change in Tear film break up time (TFBUT)
timeFrame: change from baseline in tear film break up time at 30 minutes post-CAE
measure: Change in Conjunctival Redness
timeFrame: change from baseline in conjunctival redness at 30 minutes post-CAE
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: 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
name: Tarek Shazly, MD
role: PRINCIPAL_INVESTIGATOR
References: