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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Cataract; Ocular Inflammation; Pain

Treatments: Drug: Vehicle Gel; Drug: Loteprednol Etabonate Ophthalmic Gel dosed BID; Drug: Loteprednol Etabonate Ophthalmic Gel dosed TID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02786901

875

Details and patient eligibility

About

Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Full description

A Phase 3, Multi-Center, Double-Masked, Vehicle Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
2. Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
3. Be willing and able to comply with all treatment and follow-up/study procedures.
4. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery).
5. In the Investigator's opinion, have potential postoperative pin-holed Snellen visual acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least 20/200 in the fellow eye.

Key Exclusion Criteria:

1. 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.
2. Be a female subject who is pregnant or breastfeeding.
3. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200).
4. Have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 3 patient groups, including a placebo group

Loteprednol Etabonate Ophthalmic Gel dosed TID

Experimental group

Description:

Gel

Treatment:

Drug: Loteprednol Etabonate Ophthalmic Gel dosed TID

Loteprednol Etabonate Ophthalmic Gel dosed BID

Experimental group

Description:

Gel

Treatment:

Drug: Loteprednol Etabonate Ophthalmic Gel dosed BID

Vehicle Gel

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle Gel