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Kynex Versus Refresh Plus Study in Subject With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00809198
First received: December 16, 2008
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Dry Eye
 Other: Sodium Hyaluronate
Other: Carboxymethylcellulose sodium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Cornea Staining Score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dry Eye and symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00809198     History of Changes
Other Study ID Numbers: RM-08-06
Study First Received: December 16, 2008
Last Updated: February 1, 2012
Health Authority: Korea: IRB

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
 Carboxymethylcellulose Sodium
Hyaluronic Acid
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013