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NCT00128245 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

A Phase 2 study of Keratoconjunctivitis Sicca, sponsored by Novartis.

Completed
Registry status
Phase 2
Development phase
440
Enrollment target
1
Study location

NCT00128245 is a Phase 2 study of Keratoconjunctivitis Sicca that has completed, run by Novartis. The registered enrollment target is 440 participants, above the 123-participant average among 9 other Keratoconjunctivitis Sicca trials with a reported enrollment target (258% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00128245, a Phase 2 study of Keratoconjunctivitis Sicca, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 2
Development phase
440 participants
Enrollment target
1
Study location

Study Summary

This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

Conditions Studied

Interventions

  • DRUG Vehicle
  • DRUG Pimecrolimus

Study Locations (1)

New Jersey

  • Novartis - East Hanover

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2004-09
Est. Completion 2006-12
Phase Phase 2

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00128245

The ClinicalTrials.gov registry entry for NCT00128245 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 123-participant average among 9 other Keratoconjunctivitis Sicca trials with a reported enrollment target (258% higher). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Keratoconjunctivitis Sicca appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.

NCT00128245 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT00128245 about?

NCT00128245 is a clinical study titled "Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca". This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

What is the current status of trial NCT00128245?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 440 participants. The study started on 2004-09. Estimated completion is 2006-12.

What conditions does trial NCT00128245 study?

This clinical trial studies the following conditions: Keratoconjunctivitis Sicca.

What interventions are being tested in trial NCT00128245?

The interventions under investigation include: Vehicle (DRUG), Pimecrolimus (DRUG).

Who is sponsoring clinical trial NCT00128245?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00128245 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.