← Back to Search

Other

Rebamipide for Dry Eye Syndrome

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks4
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fluorescein Corneal Staining (FCS) Score From Baseline
Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline

Side effects data

From 2011 Phase 3 trial • 154 Patients • NCT00818324
22%
Nasopharyngitis
14%
Dysgeusia (bitter taste)
5%
Trichiasis
5%
Conjunctival haemorrhage
5%
Conjunctivitis
5%
Conjunctivitis allergic
4%
Back pain
4%
Rhinitis allergic
4%
Contusion
4%
Eye irritation
4%
White blood cell count decreased
3%
Eye pain
3%
Vision blurred
3%
Visual acuity reduced
3%
Cystitis
3%
Gastroenteritis
3%
Eye discharge
3%
Glucose urine present
3%
Blood urea increased
3%
Blepharitis
3%
Corneal disorder
3%
Abdominal discomfort
3%
Dental caries
3%
Dizziness
3%
Eczema
3%
Conjunctival hyperaemia
2%
Retinal haemorrhage
2%
Gamma-glutamyltransferase increased
2%
Abnormal sensation in eye
2%
Diarrhoea
2%
Conjunctivitis bacterial
2%
Ocular discomfort
1%
Lacrimation decreased
1%
Headache
1%
Periodontitis
1%
Stomatitis
1%
Meibomian gland dysfunction
1%
Lacrimation increased
1%
Osteoarthritis
1%
Dacryocystitis
1%
Insomnia
1%
Peripheral coldness
1%
Surgical vascular shunt
1%
Dry eye
1%
Foreign body sensation in eyes
1%
Dacryostenosis acquired
1%
Dyspepsia
1%
Urinary tract infection
1%
Foreign body in eye
1%
Pain in extremity
1%
Dermatitis contact
1%
Hyperkeratosis
1%
Meibomian gland discharge
1%
Eye pruritus
1%
Hypothyroidism
1%
Femur fracture
1%
Arthralgia
1%
Breast cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
2% Rebamipide Group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RebamipideExperimental Treatment1 Intervention
Instillation,4 times/day for 4 weeks
Group II: HyaluronateActive Control1 Intervention
Instillation,6 times/day for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rebamipide
FDA approved

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Co., Ltd.Lead Sponsor
204 Previous Clinical Trials
97,716 Total Patients Enrolled
Eiji MurakamiStudy ChairOPCJ-DDO
4 Previous Clinical Trials
565 Total Patients Enrolled
~11 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top