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Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105910
First Posted: April 19, 2010
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Alcon Research
  Purpose
To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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

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

Enrollment: 70
Study Start Date: February 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01105910     History of Changes
Other Study ID Numbers: SMA-09-21
First Submitted: April 15, 2010
First Posted: April 19, 2010
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
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents