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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

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%
Conjunctival haemorrhage
5%
Conjunctivitis
5%
Conjunctivitis allergic
5%
Trichiasis
4%
Back pain
4%
Contusion
4%
White blood cell count decreased
4%
Rhinitis allergic
4%
Eye irritation
3%
Blood urea increased
3%
Gastroenteritis
3%
Glucose urine present
3%
Blepharitis
3%
Eye discharge
3%
Eye pain
3%
Vision blurred
3%
Visual acuity reduced
3%
Cystitis
3%
Corneal disorder
3%
Abdominal discomfort
3%
Dental caries
3%
Dizziness
3%
Eczema
3%
Conjunctival hyperaemia
2%
Gamma-glutamyltransferase increased
2%
Abnormal sensation in eye
2%
Retinal haemorrhage
2%
Diarrhoea
2%
Conjunctivitis bacterial
2%
Ocular discomfort
1%
Osteoarthritis
1%
Insomnia
1%
Headache
1%
Dacryocystitis
1%
Peripheral coldness
1%
Surgical vascular shunt
1%
Dry eye
1%
Lacrimation decreased
1%
Lacrimation increased
1%
Meibomian gland dysfunction
1%
Periodontitis
1%
Stomatitis
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

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
97,714 Total Patients Enrolled
Eiji MurakamiStudy ChairOPCJ-DDO
4 Previous Clinical Trials
565 Total Patients Enrolled
~12 spots leftby Sep 2025
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