Evaluation of the Repeated Usage of Systane Ultra Eyedrop

NCT ID: NCT01051804

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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Comparison of two contact lens solutions.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Systane Ultra

Systane Ultra Lubricant Eye Drops

Group Type EXPERIMENTAL

Systane Ultra

Intervention Type OTHER

Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks

Optive

Optive Lubricant Eye Drops

Group Type ACTIVE_COMPARATOR

Optive lubricant Eye Drops

Intervention Type OTHER

Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Interventions

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Systane Ultra

Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks

Intervention Type OTHER

Optive lubricant Eye Drops

Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SMA-09-33

Identifier Type: -

Identifier Source: org_study_id

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