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

Bausch & Lomb Incorporated406 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

406

Conditions

Inflammation Pain

Interventions

Vehicle of Loteprednol EtabonateDRUG

1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.

Loteprednol EtabonateDRUG

1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are at least 18 years of age. * Subjects who are candidates 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 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 VA 20/200 or worse in the non-study eye.

Locations (1)

Bausch & Lomb, Inc.

Rochester, New York, United States

Outcomes

Primary Outcomes

Resolution of Anterior Chamber Cells (ACC).

Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.

Time frame: Visit 5 (Postoperative day 8)

Grade 0 Pain

Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

Time frame: Visit 5 (Postoperative Day 8)

Secondary Outcomes

Resolution of Anterior Chamber Cells.

Study eyes with complete resolution of anterior chamber cells (ACC)

Time frame: At visits 4-7- postoperative day 3, 8,15 & 18

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.