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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Inflammation; Cataract; Pain

Treatments: Drug: Vehicle (TID); Drug: Vehicle (BID); Drug: Loteprednol Etabonate Gel (TID); Drug: Loteprednol Etabonate Gel (BID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01996839

842

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel

Full description

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

Enrollment: 514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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514 participants in 4 patient groups

Loteprednol Etabonate Gel (BID)

Experimental group

Description:

Loteprednol Etabonate Gel 0.38% administered two times daily (BID).

Treatment:

Drug: Loteprednol Etabonate Gel (BID)

Vehicle (BID)

Active Comparator group

Description:

Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID).

Treatment:

Drug: Vehicle (BID)

Loteprednol Etabonate Gel (TID)

Experimental group

Description:

Loteprednol Gel 0.38% administered three times daily (TID).

Treatment:

Drug: Loteprednol Etabonate Gel (TID)

Vehicle (TID)

Active Comparator group

Description:

Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).

Treatment:

Drug: Vehicle (TID)