None listed
Conditions
Interventions
Drug : 1) Investigational drug: Kynex3 Eye Drops
? Formulation and appearance: Colorless, transparent, homogeneous liquid eye drops in colorless, transparent plastic containers
? Active ingredient: 0.
sodium hyaluronate
? Volume: 0.5ml
? Storage condition: Room temperature
2) Control drug: Kynex Eye Drops
? Formulation and appearance: Colorless, transparent, viscous, water-soluble and liquefi
sodium hyaluronate
? Volume: 0.5ml
? Storage condition: Room temperature
3) Treatment method
Approximately 60 eligible subjects will be randomized to either of the two groups for 8 weeks of treat
sodium hyaluronate for 4 weeks, 4 times daily(1-2drops / time) and then 0.1%
sodium hyaluronate for 4 weeks, 4 times daily(1-2drops / time). Group 2 will instill 1-2 drops of 0.1%
sodium hyaluronate for 4 weeks, 4 times daily(1-2drops / time) and then 0.3%
sodium hyaluronate for 4 weeks, 4 times daily(1-2drops / time).
Sponsors
Gyeongsang National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Fluorescein staining of the cornea;Standardized Patient Evaluation of Eye Dryness Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactHaejin Kim
Gyeongsang National University Hospital
Outcome results
None listed