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Completed

NCT Number: NCT01547936

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

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.

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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