Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Ocular Inflammation

Treatments: Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment; Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645671

525

Details and patient eligibility

About

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who are candidate for routine, uncomplicated cataract surgery
2. 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

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Loteprednol Etabonate

Experimental group

Description:

Loteprednol etabonate 0.5% ophthalmic ointment

Treatment:

Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment

Vehicle

Placebo Comparator group

Description:

Vehicle of loteprednol etabonate ointment

Treatment:

Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment