This trial is active, not recruiting.

Condition dry eye
Sponsor University of Miami
Collaborator Allergan
Start date August 2011
End date December 2016
Trial size 60 participants
Trial identifier NCT00706940, 20080340


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 90 years 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.

Additional Information

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
Principal investigator Jianhua Wang, MD, PhD
Description Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Miami.