Tear Dynamics After Restasis Treatment in Dry Eye Patients

NCT00706940 | Completed

• 1 other identifier: 20080340
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

dry eye; Optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.

  3 months for treatment and follow-up of 6 months after discontinuation of study treatment.

• Tear meniscus volume after treatment

  Significant increase in tear meniscus volume was found in patients after 3 months of treatment.

  3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

dry eye patients more than 18 yrs old

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Allergan: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jianhua Wang, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: August 1, 2011
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

US (1)