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

Sponsor

ORA, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01547936

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca

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.

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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 Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

ORA, Inc.

Investigators

Principal Investigator: Tarek Shazly, MD, 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ORA, Inc.

ClinicalTrials.gov Identifier:

NCT01547936

Other Study ID Numbers:

12-270-0002

First Posted:

Mar 8, 2012

Last Update Posted:

Mar 8, 2012

Last Verified:

Mar 1, 2012

Additional relevant MeSH terms:

Keratoconjunctivitis

Keratoconjunctivitis Sicca

Dry Eye Syndromes

Study Results

No Results Posted as of Mar 8, 2012