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

Phase 3

Completed

• Conditions: Inflammation; Pain; Cataract
• Interventions: Drug: Loteprednol Etabonate Gel (BID); Drug: Vehicle Gel (BID)

• Registration Number: NCT02208297
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2014-09
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Disposition First Submitted: 2018-12-08
• Disposition First Submitted QC: 2018-12-08
• Disposition First Posted: 2018-12-11
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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 intraocular lens (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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol Etabonate Gel (BID)	Loteprednol Etabonate Gel (BID)	Loteprednol Etabonate Gel 0.38% administered two times daily (BID)
Vehicle Gel (BID)	Vehicle Gel (BID)	Vehicle gel administered two times daily (BID)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells	8 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Grade 0 Pain in the Study Eye.	8 days	Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst).
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit	18 days	White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.	18 days	Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Bridgewater, New Jersey, United States