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Kynex Versus Refresh Plus Study in Subject 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: NCT00809198
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Sodium Hyaluronate Other: Carboxymethylcellulose sodium Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Kynex Versus Refresh Plus in Subjects With Mild to Moderate Dry Eye - A Parallel Group, Randomized, Masked Study
Study Start Date : December 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sodium Hyaluronate
Sodium Hyaluronate (Kynex)
Other: Sodium Hyaluronate
Other Name: Kynex
Active Comparator: Carboxymethylcellulose sodium
Carboxymethylcellulose sodium (Refresh Plus)
Other: Carboxymethylcellulose sodium
Other Name: Refresh Plus



Primary Outcome Measures :
  1. Cornea Staining Score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Dry Eye and symptoms [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 years of age or older, of any race and either sex.
  • Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
  • Criteria for the diagnosis must include the following two characteristics at Visit 1 (Day 1):
  • Subjects' assessment of dry eye status (answer of at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?"
  • Sodium fluorescein (NaFl) corneal staining score sum of ≥3 in either eye (NEI scoring system).
  • Able and willing to follow study instructions.

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from this study:
  • History or evidence of ocular or intraocular surgery in either eye within the past three months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Use of topical ocular medications during the study period.
  • Subjects using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
  • Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
  • Subjects unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
  • Current punctal occlusion of any type (e.g. collagen plugs, silicone plugs).
  • Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
  • Participation in any investigational drug or device study within 30 days of entering this study.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00809198     History of Changes
Other Study ID Numbers: RM-08-06
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium
Refresh Plus
Dry Eye
Cornea Staining
TBUT

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Carboxymethylcellulose Sodium
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Laxatives
Gastrointestinal Agents