Kynex Versus Refresh Plus Study in Subject With Dry Eye

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Other: Carboxymethylcellulose sodium; Other: Sodium Hyaluronate

• Registration Number: NCT00809198
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxymethylcellulose sodium	Carboxymethylcellulose sodium	Carboxymethylcellulose sodium (Refresh Plus)
Sodium Hyaluronate	Sodium Hyaluronate	Sodium Hyaluronate (Kynex)

Primary Outcome Measures

Name	Time	Method
Cornea Staining Score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Dry Eye and symptoms	8 weeks