Evaluation of the Repeated Usage of Systane Ultra Eyedrop

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Other: Systane Ultra; Other: Optive lubricant Eye Drops

• Registration Number: NCT01051804
• Lead Sponsor: Alcon Research

Brief Summary

Comparison of two contact lens solutions.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2010-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane Ultra	Systane Ultra	Systane Ultra Lubricant Eye Drops
Optive	Optive lubricant Eye Drops	Optive Lubricant Eye Drops

Primary Outcome Measures

Name	Time	Method
Improvement in objective vision	4 weeks

Secondary Outcome Measures

Name	Time	Method
Measurement of tear film evaporation	4 weeks