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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Tear meniscus volume after treatment
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Tear meniscus volume after treatment
Time Frame: 3 months
Significant increase in tear meniscus volume was found in patients after 3 months of treatment.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jianhua (Jay) Wang, MD, PhD
Associate Professor
University of Miami