Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00201981 · ClinicalTrials.gov registry record · Phase 3
A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 755
- Enrollment target
NCT00201981: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00201981 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 755 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00201981, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 755 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Placebo
- DRUG Rebamipide 1%
- DRUG Rebamipide 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 755 participants |
| Start Date | 2004-05-01 |
| Est. Completion | 2007-02-01 |
| Phase | Phase 3 |
What the finished NCT00201981 record still lists
NCT00201981 is an interventional study that assigns participants to a tested intervention. The registered 755 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00201981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00201981 about?
NCT00201981 is a clinical study titled "A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo". 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).
What is the current status of trial NCT00201981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2004-05-01. Estimated completion is 2007-02-01.
What interventions are being tested in trial NCT00201981?
The interventions under investigation include: Placebo (DRUG), Rebamipide 1% (DRUG), Rebamipide 2% (DRUG).
Who is sponsoring clinical trial NCT00201981?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00201981's enrollment target sits among peer trials
755 459th of 2000 higher than 1,541 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05869149 · 756 participants · NA
Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
- NCT06095583 · 756 participants · Phase 3
Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
- NCT05379985 · 754 participants · Phase 1
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
- NCT05427370 · 754 participants · NA
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI