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OpenTrials
Completed

NCT Number: NCT02522312

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hazleton Eye Specialists

Hazleton, Pennsylvania, 18202, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

No intervention

Other

No drug is administered in this study

Primary outcomes

  1. Improvement of Schirmer's Test score

    Time frame: 6 months

  2. Increased contact lens wear time

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hazleton Eye Specialists

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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