Status:
COMPLETED
Tear Dynamics After Restasis Treatment in Dry Eye Patients
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Allergan
Conditions:
Dry Eye
Eligibility:
All Genders
18-90 years
Brief Summary
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.
Detailed Description
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
Eligibility Criteria
Inclusion
- The participant will be eligible for entry in the study if s/he:
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas;
- Has 20/100 uncorrected visual acuity or better;
- Has dry eye according to the study definition of DES (study subjects);
- Has not use Restasis within 3 months.
Exclusion
- The subjects will ineligible for entry into the study if s/he:
- Has any systemic disease affecting ocular health except for Sjögren's syndrome;
- Is using any systemic or topical medications that will affect ocular health except for artificial tears;
- Has an active ocular disease other than DES, or Sjögren's syndrome
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
- Has worn rigid gas permeable lenses within 1 year and during the study;
- Has had surgery or an eye injury within 6 months;
- Was a soft contact lens wearer within 2 weeks and during the study.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00706940
Start Date
August 1 2011
End Date
December 31 2016
Last Update
April 25 2017
Active Locations (1)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136