Dry Eye
Conditions
Keywords
Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium, Refresh Plus, Dry Eye, Cornea Staining, TBUT
Brief summary
The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.
Interventions
OTHERSodium Hyaluronate
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cornea Staining Score | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Dry Eye and symptoms | 8 weeks |
Outcome results
None listed