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Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01105910
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : November 18, 2016
Sponsor:
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

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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
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01105910    
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:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions