Kynex Versus Refresh Plus Study in Subject With Dry Eye

NCT00809198 | Completed Phase 4

• 1 other identifier: RM-08-06
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dry Eye

Keywords

Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium; Refresh Plus; Dry Eye; Cornea Staining; TBUT

Outcome Measures

Primary Outcomes (1)

• Cornea Staining Score

  8 weeks

Secondary Outcomes (1)

• Dry Eye and symptoms

  8 weeks

Study Arms (2)

Sodium Hyaluronate

EXPERIMENTAL

Sodium Hyaluronate (Kynex)

Other: Sodium Hyaluronate

Carboxymethylcellulose sodium

ACTIVE COMPARATOR

Carboxymethylcellulose sodium (Refresh Plus)

Other: Carboxymethylcellulose sodium

Interventions

Sodium Hyaluronate OTHER

Also known as: Kynex

Sodium Hyaluronate

Carboxymethylcellulose sodium OTHER

Also known as: Refresh Plus

Carboxymethylcellulose sodium

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Methylcellulose; Cellulose; Glucans

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 3, 2012

Record last verified: 2012-02