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Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

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: NCT01086774
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
Evaluation of the optical effects of Systane Ultra

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Ultra Lubricant Eye Drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
Experimental: Systane Ultra
Systane Ultra Lubricant Eye Drops
Other: Systane Ultra Lubricant Eye Drops
Single drop in both eyes




Primary Outcome Measures :
  1. Improvement in maximum blink interval (MBI) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Tear film stability and contrast sensitivity [ Time Frame: 1 day ]


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:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years or more.
  2. Subjects must have Tear Break Up Time (TBUT) < 5 seconds
  3. Subjects must have a maximum blink interval (MBI) < 10 seconds
  4. Subjects must be willing to comply with all study requirements.
  5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
  2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
  3. Subjects with known sensitivity to planned study concomitant medications
  4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
  5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01086774    
Other Study ID Numbers: SMA-09-39
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Alcon Research:
Dry eye
Tear Film Stability
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