Kynex Versus Refresh Plus Study in Subject With Dry Eye

NCT ID: NCT00809198

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

Brief Summary

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

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sodium Hyaluronate

Sodium Hyaluronate (Kynex)

Group Type: EXPERIMENTAL

Sodium Hyaluronate

Intervention Type: OTHER

Carboxymethylcellulose sodium

Carboxymethylcellulose sodium (Refresh Plus)

Group Type: ACTIVE_COMPARATOR

Carboxymethylcellulose sodium

Intervention Type: OTHER

Interventions

Sodium Hyaluronate

Intervention Type: OTHER

Carboxymethylcellulose sodium

Intervention Type: OTHER

Other Intervention Names

Kynex; Refresh Plus

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RM-08-06

Identifier Type: -

Identifier Source: org_study_id