Oasys vs. Extreme H20 Xtra 59

February 13, 2008 updated by: Innovative Medical
To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hazleton, Pennsylvania, United States, 18202
        • Hazleton Eye Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female at least 19 years of age
  • Contact Lens Wearers
  • Patients with mild to moderate symptoms of dry eye

Exclusion Criteria:

  • male or female younger than 19 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Restasis, Refresh Endura
  1. Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
  2. Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
Active Comparator: 1
Drug: Restasis, Refresh Endura
  1. Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
  2. Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparing performance of contact lens
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dry eye
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

Investigators

  • Principal Investigator: Thomas Kislan, OD, Hazleton Eye Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 13, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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