Kynex Versus Refresh Plus Study in Subject With Dry Eye

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809198
• Other study ID #: RM-08-06
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2008
• Last updated: February 1, 2012
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: IRB
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Sodium Hyaluronate

• Carboxymethylcellulose sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cornea Staining Score		8 weeks	Yes
Secondary	Dry Eye and symptoms		8 weeks	Yes