Dry Eye Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.
Interventions
Instill one drop into each eye 4 times a day for 4 weeks.
Instill one drop into each eye 4 times a day for 4 weeks.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Kubota Vision Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of dry eye-related ocular symptoms for at least 20 months. * Meet protocol-defined criteria for corneal and conjunctival staining. * Meet protocol-defined criteria for ocular discomfort.
Exclusion criteria
* Active anterior segment ocular disease other than dry eye syndrome. * Inability to suspend the use of topical ophthalmic medications throughout the duration of the study. * Inability to suspend the use of contact lenses for the duration of the study. * Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns. * Received any other investigational product within 4 months before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary ocular sign: Fluorescein corneal staining total score | 4 weeks |
| Primary ocular symptom: Worst ocular symptom severity score | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Worst ocular symptom severity score | 2 weeks |
| Fluorescein corneal staining total score | 2 weeks |
Countries
United States
Outcome results
None listed