NCT02522312

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

July 29, 2015

Last Update Submit

March 1, 2016

Conditions

Dry Eye Syndrome

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Improvement of Schirmer's Test score

    6 months

  • Increased contact lens wear time

    6 months

Interventions

No InterventionOTHER

No drug is administered in this study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazleton Eye Specialists

Hazleton, Pennsylvania, 18202, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Thomas P Kislan, Dr.

    Owner

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor at and Owner of Hazleton Eye Specialists

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 13, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)