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Tear Dynamics After Restasis Treatment in Dry Eye Patients

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ClinicalTrials.gov Identifier: NCT00706940
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami

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.

Condition or disease
Dry Eye

Detailed Description:
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Study Type : Observational
Actual Enrollment : 60 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources




Primary Outcome Measures :
  1. 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. ]
  2. Tear meniscus volume after treatment [ Time Frame: 3 months ]
    Significant increase in tear meniscus volume was found in patients after 3 months of treatment.



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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00706940     History of Changes
Other Study ID Numbers: 20080340
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Jianhua (Jay) Wang, MD, PhD, University of Miami:
dry eye
Optical coherence tomography

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