Study of Rebamipide Eye Drops to Treat Dry Eye

Otsuka

Status and phase

Completed

Phase 3

Conditions

Keratoconjunctivitis Sicca

Treatments

Drug: Rebamipide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00201955

37E-03-201

Details and patient eligibility

About

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Full description

There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

must have symptoms of dry eye for a minimum of 6 months
must be able to sign and date an informed consent

Exclusion criteria

presence of anterior segment disease
glaucoma or ocular hypertension
using Restasis
use of topically instilled ocular medications during study
use of contact lenses
history of ocular surgery within 12 months
females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
presence of Stevens-Johnson syndrome
any anticipated change in medication through-out study
concurrent involvement in another study or previous receipt of this drug
cannot be safely be weaned off of ocular medications