Text Size

Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01105910
First received: April 15, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Reduction in corneal staining [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient acceptability / comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01105910     History of Changes
Other Study ID Numbers: SMA-09-21
Study First Received: April 15, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

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
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013