Tear Dynamics After Restasis Treatment in Dry Eye Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami
First received: June 26, 2008
Last updated: June 11, 2013
Last verified: June 2013
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||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
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
dry eye patients more than 18 yrs old
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706940
|Bascom Palmer Eye Institute
|Miami, Florida, United States, 33136 |
University of Miami
||Jianhua Wang, MD, PhD
||University of Miami
No publications provided
||Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 26, 2008
||June 11, 2013
||United States: Institutional Review Board
Keywords provided by University of Miami:
Optical coherence tomography
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs