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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01547936
First received: February 15, 2012
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in Fluorescein Staining [ Time Frame: change from baseline in staining at 30 minutes post-CAE ] [ Designated as safety issue: No ]
  • Change in Tear film break up time (TFBUT) [ Time Frame: change from baseline in tear film break up time at 30 minutes post-CAE ] [ Designated as safety issue: No ]
  • Change in Conjunctival Redness [ Time Frame: change from baseline in conjunctival redness at 30 minutes post-CAE ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with dry eye disease

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547936

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01547936     History of Changes
Other Study ID Numbers: 12-270-0002
Study First Received: February 15, 2012
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013