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Tear Dynamics After Restasis Treatment in Dry Eye Patients

This study has been completed.
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami Identifier:
First received: June 26, 2008
Last updated: April 24, 2017
Last verified: April 2017
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.

Dry Eye

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ]
    Significant increase in tear meniscus volume was found in patients after 3 months of treatment.

Enrollment: 60
Study Start Date: August 2011
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Detailed Description:
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dry eye patients more than 18 yrs 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.
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Please refer to this study by its identifier: NCT00706940

United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Principal Investigator: Jianhua Wang, MD, PhD University of Miami
  More Information

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami Identifier: NCT00706940     History of Changes
Other Study ID Numbers: 20080340
Study First Received: June 26, 2008
Last Updated: April 24, 2017

Keywords provided by University of Miami:
dry eye
Optical coherence tomography

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on May 24, 2017