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

This study has been completed.
Information provided by (Responsible Party):
ORA, Inc. Identifier:
First received: February 15, 2012
Last updated: March 5, 2012
Last verified: March 2012
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.

Keratoconjunctivitis Sicca

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by ORA, Inc.:

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

Enrollment: 33
Study Start Date: February 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: ORA, Inc. Identifier: NCT01547936     History of Changes
Other Study ID Numbers: 12-270-0002
Study First Received: February 15, 2012
Last Updated: March 5, 2012

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on September 19, 2017