A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2015 |
End Date: | December 2015 |
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.
Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis
will be evaluated to determine success in treatment by retrospectively looking at various
outcome measures including but not limited to schirmer, staining and osmolarity levels
will be evaluated to determine success in treatment by retrospectively looking at various
outcome measures including but not limited to schirmer, staining and osmolarity levels
Inclusion Criteria:
- Male or Female, > or = 18 years of age
- Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry
eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with
Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was
newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1,
2 or 3) which required continuous medical therapy with Restasis® for a minimum
duration of 6 months post-Baseline (Visit 1);
- Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced
dosing immediately after Baseline Visit (Visit 1)
- Baseline Visit occured between 01 July 2012 and 01 January 2014;
- Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test
score <10 mm, decreased tear lake, TBUT <10 seconds, conjunctival staining, tear
osmolarity >310 mOsmol/L
- Subject had charted tolerability and efficacy data reflecting at least one follow-up
visit following Restasis® treatment initiation; and
- Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a
minimum duration of 6 months post-Baseline (Visit 1)
Exclusion Criteria:
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