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OpenTrials
Completed

NCT Number: NCT00645671

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

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Key information

Conditions

Ocular Inflammation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

John Hunkeler, MD

Overland Park, Kansas, 66210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are candidate for routine, uncomplicated cataract surgery
  • Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion criteria

  • Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
  • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
  • Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
  • Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Treatment and study plan

0.5% Loteprednol Etabonate Ophthalmic Ointment

Drug

1/2 inch ribbon four times a day for 14 days

Vehicle of Loteprednol Etabonate Ophthalmic Ointment

Drug

1/2 inch ribbon four times a day for 14 days

Primary outcomes

  1. Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.

    Time frame: Postoperative Day 8 (Visit 5)

    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.

  2. Grade 0 for Pain

    Time frame: Postoperative Day 8 (Visit 5)

    Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe

Secondary outcomes

  1. Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.

    Time frame: At each follow-up visit through day18 (Visit 7)

    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.

  2. Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare

    Time frame: Baseline and each follow-up visit through day18 (Visit 7)

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 28, 2008
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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