Status:
COMPLETED
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Ocu...
Eligibility Criteria
Inclusion
- Key
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- 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.
- Be willing and able to comply with all treatment and follow-up/study procedures.
- Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens \[IOL\] implantation, not combined with any other surgery).
- 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
- 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.
- Be a female subject who is pregnant or breastfeeding.
- Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200).
- 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).
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02786901
Start Date
June 1 2016
End Date
July 1 2017
Last Update
January 8 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Valeant Site 01
Phoenix, Arizona, United States, 85032
2
Valeant Site 03
Oceanside, California, United States, 92056
3
Valeant Site 05
Miami, Florida, United States, 33143
4
Valeant Site 04
Quincy, Massachusetts, United States, 02169