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A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

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ClinicalTrials.gov Identifier: NCT02522312
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas P. Kislan, Hazleton Eye Specialists

Brief Summary:
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.

Condition or disease Intervention/treatment
Dry Eye Syndrome Other: No Intervention

Detailed Description:
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

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear


Intervention Details:
  • Other: No Intervention
    No drug is administered in this study


Primary Outcome Measures :
  1. Improvement of Schirmer's Test score [ Time Frame: 6 months ]
  2. Increased contact lens wear time [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522312


Locations
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United States, Pennsylvania
Hazleton Eye Specialists
Hazleton, Pennsylvania, United States, 18202
Sponsors and Collaborators
Hazleton Eye Specialists
Investigators
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Principal Investigator: Thomas P Kislan, Dr. Owner

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Responsible Party: Dr. Thomas P. Kislan, Doctor at and Owner of Hazleton Eye Specialists, Hazleton Eye Specialists
ClinicalTrials.gov Identifier: NCT02522312     History of Changes
Other Study ID Numbers: IIT-00864
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Dr. Thomas P. Kislan, Hazleton Eye Specialists:
Dry Eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases