Clinical trial NCT02786901: LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: A Phase 3, Multi-Center, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) Versus Vehicle Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Pain
Ocular Inflammation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)
timeFrame: 8 days
measure: Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)
timeFrame: 8 days
Secondary outcomes:
measure: Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.
timeFrame: 14 days
measure: Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit
timeFrame: 14 days
measure: Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit
timeFrame: 14 days
measure: Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit
timeFrame: 14 days
measure: Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit
timeFrame: 14 days
measure: Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8)
timeFrame: 8 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valeant Site 01
state: Arizona
city: Oceanside
country: United States
facility: Valeant Site 03
state: California
city: Miami
country: United States
facility: Valeant Site 05
state: Florida
city: Quincy
country: United States
facility: Valeant Site 04
state: Massachusetts
city: Kansas City
country: United States
facility: Valeant Site 06
state: Missouri
city: Saint Louis
country: United States
facility: Valeant Site 02
state: Missouri
Study officials:
affiliation: Valeant Pharmaceuticals
name: Denise Ramjit
role: STUDY_DIRECTOR
References: