Tear Dynamics After Restasis Treatment in Dry Eye Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT00706940
First received: June 26, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition
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. ] [ Designated as safety issue: No ]
  • Tear meniscus volume after treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Significant increase in tear meniscus volume was found in patients after 3 months of treatment.


Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

dry eye patients more than 18 yrs old

Criteria

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.
  Contacts and Locations
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

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

No publications provided

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00706940     History of Changes
Other Study ID Numbers: 20080340
Study First Received: June 26, 2008
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on October 21, 2014