Kynex Versus Refresh Plus Study in Subject With Dry Eye

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00809198

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cornea Staining Score [8 weeks]

Secondary Outcome Measures

Dry Eye and symptoms [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.