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NCT Number: NCT02208297

Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

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Key information

Conditions

Inflammation Cataract Eye Diseases Lens Diseases 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 Incorporated

Bridgewater, New Jersey, 08807, United States

About this study

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Visit 1 (Screening Visit)

  • Be willing and able to comply with all treatment and follow-up/study procedures.
  • Be a candidate for routine, uncomplicated cataract surgery.

Visit 3 (Postoperative Day 1)

  • Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
  • Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

Exclusion criteria

  • Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
  • Have known hypersensitivity or contraindication to the study drug(s) or their components.

Treatment and study plan

Loteprednol Etabonate Gel (BID)

Drug

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

Other names: Lotemax

Vehicle Gel (BID)

Drug

One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Other names: Vehicle

Primary outcomes

  1. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells

    Time frame: 8 days

    White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.

  2. Percentage of Participants With Grade 0 Pain in the Study Eye.

    Time frame: 8 days

    Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.

Secondary outcomes

  1. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit

    Time frame: 18 days

    White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.

  2. Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.

    Time frame: 18 days

    White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.

  3. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.

    Time frame: 18 days

    Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.

  4. Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.

    Time frame: 18 days

    White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Sep 25, 2020

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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