Comparative Study for the Compliance and Efficacy of Kynex and Kynex3 in Dry Eye Patients
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004912
- Lead Sponsor
- Gyeongsang National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
? Adult males and females aged =19 years
? The diagnostic criteria at Visit 1 (Day 1) must include the following two characteristics:
? TBUT test result =10 seconds
? Subject’s assessment of dry eye condition (answers at least sometimes” to the question How often do you feel eye dryness enough that you want to use eye drops?”)
? Patients who are capable of understanding and signing an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)
? Those who are capable of understanding and voluntarily agree to this study
? History of ocular or intraocular surgery on either eye within the last 6 months
? History of intolerance or hypersensitivity to any constituent of the study drugs
? In the presence of a history or evidence of herpes simplex virus epithelial keratitis; vaccination, active or recent corneal and/or conjunctival varicella virus disease. Ocular rosacea, a chronic bacterial disease of the cornea and/or conjunctiva and/or eyelid, mycobacterial ocular infection and/or ocular fungal disease
? Use of topical ophthalmic drugs during the study
? Subjects who are using a systemic medication which may induce dry eye (i.e., anti-common-cold and antiallergic drugs, tricyclic antidepressants, hormone replacement therapy) may not be allowed study entry if the dosage regimen has not been stable for at least 30 days prior to Visit 1. In addition, the dosage regimen should remain stable during the study.
? Eye conditions, such as active acute blepharitis, conjunctival inflammation, and iritis, or other eye conditions that may preclude safe administration of the study drug
? Those who wore contact lenses within 72 hours prior to screening or those who have to wear contact lenses or do not agree to not wearing contact lenses during the study
? Punctal occlusion (i.e., collagen plug, silicone plug) within 90 days prior to screening
? Vision correction surgery, such as laser-assisted in situ keratomileusis (LASIK), within 12 months prior to screening
? Autoimmune disease (e.g., Sjogren’s syndrome)
? Diagnosis of psychiatric disorder that may affect the conduct of this study
? History of drug or alcohol abuse
? An investigator or study staff, a family member of the investigator, a family member of the study staff , or an individual residing in the household of such persons
? Administration of other study drug or medical device within 30 days prior to study entry
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance Questionnaire
- Secondary Outcome Measures
Name Time Method Fluorescein staining of the cornea;Standardized Patient Evaluation of Eye Dryness Questionnaire