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Completed

NCT Number: NCT01060072

Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

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Key information

Conditions

Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch & Lomb

Rochester, New York, 14609, 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 at least 18 years of age.
  • Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion criteria

  • Subjects who have known hypersensitivity or contraindication to the study drug or components.
  • Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
  • Subjects with elevated intraocular pressure (>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
  • Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.

Treatment and study plan

Loteprednol Etabonate

Drug

Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.

Vehicle of Loteprednol Etabonate

Drug

Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.

Primary outcomes

  1. Resolution of Anterior Chamber Cells.

    Time frame: Visit 5 (Postoperative day 8)

    Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

  2. Grade 0 Pain

    Time frame: Visit 5 (Postoperative day 8)

    Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain

Secondary outcomes

  1. Resolution of Anterior Chamber Cells

    Time frame: Visit 4-7 (postoperative day 3-18)

    Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

  2. Grade 0 Pain

    Time frame: Visits 4-7 (Postoperative days 3-18)

    Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain

  3. Resolution of Anterior Chamber Flare

    Time frame: Visit 4-7 (postoperative day 3-18)

    Complete resolution of flare, scored on a scale of 0-4 were 0=none and 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, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2010
Registry last updated
Jan 13, 2012

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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