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NCT00645671 · ClinicalTrials.gov registry record · Phase 3

Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

A Phase 3 study, sponsored by Bausch & Lomb Incorporated.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target

NCT00645671: Completed Phase 3 study, sponsored by Bausch & Lomb Incorporated.

NCT00645671 is a Phase 3 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00645671, a Phase 3 study, has completed, sponsored by Bausch & Lomb Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target

Study Summary

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Primary Outcome

A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Interventions

  • DRUG 0.5% Loteprednol Etabonate Ophthalmic Ointment
  • DRUG Vehicle of Loteprednol Etabonate Ophthalmic Ointment

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2008-03
Est. Completion 2009-03
Phase Phase 3
Bausch & Lomb Incorporated

174 total trials

What the finished NCT00645671 record still lists

NCT00645671 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 2 interventions - of which 0.5% Loteprednol Etabonate Ophthalmic Ointment is the first listed.

NCT00645671 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00645671 about?

NCT00645671 is a clinical study titled "Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery". To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

What is the current status of trial NCT00645671?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2008-03. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00645671?

The interventions under investigation include: 0.5% Loteprednol Etabonate Ophthalmic Ointment (DRUG), Vehicle of Loteprednol Etabonate Ophthalmic Ointment (DRUG).

Who is sponsoring clinical trial NCT00645671?

This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00645671's enrollment target sits among peer trials

400 922nd of 2000 higher than 1,039 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

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Source: ClinicalTrials.gov NCT00645671, the US trial registry maintained by the National Library of Medicine. NCT00645671 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.