Tear Dynamics After Restasis Treatment in Dry Eye Patients



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 90
Updated:4/26/2017
Start Date:August 2011
End Date:December 31, 2016

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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

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.

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

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.
We found this trial at
1
site
900 Northwest 17th Street
Miami, Florida 33136
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from
Miami, FL
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