Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

Alcon

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Dry Eye Subjects

Treatments: Other: Systane Ultra Lubricant Eye Drops; Other: Sensitive Eyes Eye Drops (Bausch & Lomb)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105910

SMA-09-21

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Systane Ultra

Experimental group

Description:

Systane Ultra Lubricant Eye Drops

Treatment:

Other: Systane Ultra Lubricant Eye Drops

Sensitive Eyes

Active Comparator group

Description:

Sensitive Eyes Eye Drops (Bausch \& Lomb)

Treatment:

Other: Sensitive Eyes Eye Drops (Bausch & Lomb)