Evaluation of the Repeated Usage of Systane Ultra Eyedrop

January 31, 2012 updated by: Alcon Research
Comparison of two contact lens solutions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or more.
  • Non contact lens wearer.

  • Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

    • Score ≥13 for OSDI Questionnaire total score; AND
    • Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
  • Best visual acuity of 6/9 or better in each eye.
  • Willingness to adhere to the instructions set in the clinical protocol.
  • Signature of the subject informed consent form.

Exclusion Criteria:

  • Use of systemic medication which might produce dry eye side effects.
  • Systemic disease which might produce dry eye side effects.
  • Active ocular infection.
  • Use of ocular medication.
  • Significant ocular anomaly.
  • Previous ocular surgery
  • Previous use of Restasis
  • Any medical condition that might be prejudicial to the study.
  • The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
  • The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
  • The subject, based on their knowledge, must NOT have diabetes.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systane Ultra
Systane Ultra Lubricant Eye Drops
Other: Systane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Active Comparator: Optive
Optive Lubricant Eye Drops
Other: Optive lubricant Eye Drops
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in objective vision
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of tear film evaporation
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Alcon Research

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

November 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 18, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-33

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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