Tear Dynamics After Restasis Treatment in Dry Eye Patients
This trial is active, not recruiting.
|Sponsor||University of Miami|
|Start date||August 2011|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT00706940, 20080340|
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.
Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.
time frame: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
Tear meniscus volume after treatment
time frame: 3 months
Male or female participants from 18 years up to 90 years old.
Inclusion Criteria: The participant will be eligible for entry in the study if s/he: 1. Is at least 18 years old and has full legal capacity to volunteer; 2. Has read and signed the IRB Informed Consent Document; 3. Is willing and able to follow participant instructions; 4. Has clear corneas; 5. Has 20/100 uncorrected visual acuity or better; 6. Has dry eye according to the study definition of DES (study subjects); 7. Has not use Restasis within 3 months. Exclusion Criteria: The subjects will ineligible for entry into the study if s/he: 1. Has any systemic disease affecting ocular health except for Sjögren's syndrome; 2. Is using any systemic or topical medications that will affect ocular health except for artificial tears; 3. Has an active ocular disease other than DES, or Sjögren's syndrome 4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; 5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES; 6. Has worn rigid gas permeable lenses within 1 year and during the study; 7. Has had surgery or an eye injury within 6 months; 8. Was a soft contact lens wearer within 2 weeks and during the study.
|Official title||Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment|
|Principal investigator||Jianhua Wang, MD, PhD|
|Description||Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.|
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