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Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

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ClinicalTrials.gov Identifier: NCT01105910
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Post Menopausal Dry Eye Subjects Other: Systane Ultra Lubricant Eye Drops Other: Sensitive Eyes Eye Drops (Bausch & Lomb) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : February 2010
Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Systane Ultra
Systane Ultra Lubricant Eye Drops
Other: Systane Ultra Lubricant Eye Drops
1 to 2 drops in each eye 4 times per day for 30 days
Active Comparator: Sensitive Eyes
Sensitive Eyes Eye Drops (Bausch & Lomb)
Other: Sensitive Eyes Eye Drops (Bausch & Lomb)
1 to 2 drops in each eye 4 times per day for 30 days

Primary Outcome Measures :
  1. Reduction in corneal staining [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Patient acceptability / comfort [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01105910     History of Changes
Other Study ID Numbers: SMA-09-21
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry Eye, Post Menopausal dry eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents