Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate
Brief summary
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
Interventions
DRUGAT02
eye drop for 12 weeks
DRUGAT03
eye drop for 12 weeks
DRUGAT04
eye drop for 12 weeks
DRUGAT01
eye drop for 12 weeks
Sponsors
Dhp Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female adults aged 18 years and over. * Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome. * Subjects must agree to discontinue all artificial tears from Screening for 2 weeks * Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. * Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening * Subjects must provide signed informed consent prior to participation in any study-related procedures * Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.
Exclusion criteria
* Pregnancy or lactation. * Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized. * Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. * Any active inflammation of the eye not due to KCS * Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Break Up Time (TBUT) | 12weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fluorescein staining, schirmer test, OSDI, VAS | 12 weeks |
Countries
South Korea
Outcome results
None listed