Kynex Versus Refresh Plus Study in Subject With Dry Eye

February 1, 2012 updated by: Alcon Research

The Effect of Kynex Versus Refresh Plus in Subjects With Mild to Moderate Dry Eye - A Parallel Group, Randomized, Masked Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sodium Hyaluronate
Sodium Hyaluronate (Kynex)
Other: Sodium Hyaluronate
Other Names:
  • Kynex
ACTIVE_COMPARATOR: Carboxymethylcellulose sodium
Carboxymethylcellulose sodium (Refresh Plus)
Other: Carboxymethylcellulose sodium
Other Names:
  • Refresh Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cornea Staining Score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Dry Eye and symptoms
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (ESTIMATE)

December 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-08-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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