Effect of Controlled Adverse Environment (CAE) on Tear Film Stability
Launched by ORA, INC. · Mar 5, 2012
Trial Information
Current as of August 15, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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
About Ora, Inc.
Ora, Inc. is a leading clinical research organization specializing in ophthalmic drug development and medical device testing. With a commitment to advancing eye care, Ora leverages its extensive expertise and innovative methodologies to support pharmaceutical and biotechnology companies in bringing new therapies to market. The organization offers a comprehensive suite of services, including preclinical research, clinical trial management, and regulatory consulting, ensuring that clients receive tailored solutions to meet their specific developmental needs. Ora's dedication to scientific excellence and patient safety positions it as a trusted partner in the advancement of ocular health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Andover, Massachusetts, United States
Patients applied
Trial Officials
Tarek Shazly, MD
Principal Investigator
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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