Effect of Controlled Adverse Environment (CAE) on Tear Film Stability
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
1 other identifier
observational
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedMarch 8, 2012
March 1, 2012
Same day
February 15, 2012
March 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Patients diagnosed with dry eye disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ORA, Inc.lead
Study Sites (1)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
March 8, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 8, 2012
Record last verified: 2012-03