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

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Bausch + Lomb

Status and phase

Completed
Phase 3

Conditions

Inflammation
Pain

Treatments

Drug: Vehicle of Loteprednol Etabonate
Drug: Loteprednol etabonate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

407 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

407 participants in 2 patient groups, including a placebo group

Loteprednol etabonate
Experimental group
Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Treatment:
Drug: Loteprednol etabonate
Vehicle
Placebo Comparator group
Description:
Vehicle of loteprednol etabonate ophthalmic suspension
Treatment:
Drug: Vehicle of Loteprednol Etabonate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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