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To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01160133
First received: July 9, 2010
Last updated: April 7, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.


Condition Intervention
Dry Eye
 Other: Systane
Other: Refresh Tears

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye. [ Time Frame: Baseline to visit 3 (Day 42) ] [ Designated as safety issue: Yes ]
    This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.


Enrollment: 78
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane
Systane Lubricant Eye Drops
 Other: Systane
Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Experimental: Refresh Tears
Refresh Tears Lubricant Eye Drops
 Other: Refresh Tears
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
  • A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
  • A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion Criteria:

  • A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
  • Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
  • A history of intolerance or hypersensitivity to any component of the study medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160133

Locations
India
Vasan Eye Care Hospital
Saidapet, Channai, India, 600 015
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01160133     History of Changes
Other Study ID Numbers: SMA-09-67
Study First Received: July 9, 2010
Last Updated: April 7, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Alcon Research:
Systane
Refresh Tears
Dry Eye
Moderate to Severe Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Carboxymethylcellulose Sodium
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013