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COMPLETED Phase 2

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

NCT01027013 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

Interventions

  • DRUG rebamipide 2% ophthalmic suspension
  • DRUG placebo eye drops

Study Locations (5)

Connecticut

  • The Eye Care Group, P.C. — Waterbury

Kentucky

  • Richard Eiferman, MD — Louisville

Maine

  • Central Maine Eye Care — Lewiston

Massachusetts

  • Ora, Inc — Andover

Tennessee

  • Total Eye Care, P.A. — Memphis

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2009-12
Est. Completion 2010-11
Phase Phase 2

Sponsor

Kubota Vision

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01027013

The ClinicalTrials.gov registry entry for NCT01027013 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kubota Vision, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Dry Eye Syndromes appearing as the primary indexed condition, and to 2 interventions — of which rebamipide 2% ophthalmic suspension is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01027013 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Connecticut, Kentucky, Maine. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01027013 about?

NCT01027013 is a clinical study titled "Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye". The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

What is the current status of trial NCT01027013?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2009-12. Estimated completion is 2010-11.

What conditions does trial NCT01027013 study?

This clinical trial studies the following conditions: Dry Eye Syndromes, Keratoconjunctivitis Sicca. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01027013?

The interventions under investigation include: rebamipide 2% ophthalmic suspension (DRUG), placebo eye drops (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01027013?

This trial is sponsored by Kubota Vision, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01027013 being conducted?

This trial has 5 study locations across Connecticut, Kentucky, Maine, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial