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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547936
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
ORA, Inc.

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
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 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 : February 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Primary Outcome Measures :
  1. change in tear film break up area [ Time Frame: change from baseline in tear film break up area at 30 minutes post-CAE at study visit ]

Secondary Outcome Measures :
  1. change in Fluorescein Staining [ Time Frame: change from baseline in staining at 30 minutes post-CAE ]
  2. Change in Tear film break up time (TFBUT) [ Time Frame: change from baseline in tear film break up time at 30 minutes post-CAE ]
  3. Change in Conjunctival Redness [ Time Frame: change from baseline in conjunctival redness at 30 minutes post-CAE ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with dry eye disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547936

United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
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

Responsible Party: ORA, Inc. Identifier: NCT01547936     History of Changes
Other Study ID Numbers: 12-270-0002
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases