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Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

NCT ID: NCT01105910

Last Updated: 2016-11-18

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Brief Summary

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To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.

Detailed Description

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Conditions

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Post Menopausal Dry Eye Subjects

Keywords

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Dry Eye, Post Menopausal dry eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Systane Ultra

Systane Ultra Lubricant Eye Drops

Group Type EXPERIMENTAL

Systane Ultra Lubricant Eye Drops

Intervention Type OTHER

1 to 2 drops in each eye 4 times per day for 30 days

Sensitive Eyes

Sensitive Eyes Eye Drops (Bausch \& Lomb)

Group Type ACTIVE_COMPARATOR

Sensitive Eyes Eye Drops (Bausch & Lomb)

Intervention Type OTHER

1 to 2 drops in each eye 4 times per day for 30 days

Interventions

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Systane Ultra Lubricant Eye Drops

1 to 2 drops in each eye 4 times per day for 30 days

Intervention Type OTHER

Sensitive Eyes Eye Drops (Bausch & Lomb)

1 to 2 drops in each eye 4 times per day for 30 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Post-menopausal (menses ceased more than 12 months prior to the start of the study).
2. Diagnosed for dry eye

Exclusion Criteria

1. History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
2. Active and severe blepharitis, rosacea and associated ocular sequelae.
3. Has any significant eyelid abnormality affecting lid function.
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

Countries

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United States

References

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http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye

Reference Type RESULT

Other Identifiers

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SMA-09-21

Identifier Type: -

Identifier Source: org_study_id