Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

Phase 4

Completed

• Conditions: Post Menopausal Dry Eye Subjects
• Interventions: Other: Systane Ultra Lubricant Eye Drops; Other: Sensitive Eyes Eye Drops (Bausch & Lomb)

• Registration Number: NCT01105910
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-19
• Primary Completion: 2010-12
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane Ultra	Systane Ultra Lubricant Eye Drops	Systane Ultra Lubricant Eye Drops
Sensitive Eyes	Sensitive Eyes Eye Drops (Bausch & Lomb)	Sensitive Eyes Eye Drops (Bausch \& Lomb)

Primary Outcome Measures

Name	Time	Method
Reduction in corneal staining	30 days

Secondary Outcome Measures

Name	Time	Method
Patient acceptability / comfort	30 days