LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
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
1 other identifier
interventional
600
1 country
6
Brief Summary
Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2016
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
April 14, 2020
CompletedJanuary 8, 2021
January 1, 2021
1 year
May 23, 2016
March 9, 2020
January 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)
Slit lamp examination was performed. 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. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.
8 days
Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)
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 a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.
8 days
Secondary Outcomes (6)
Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.
14 days
Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit
14 days
Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit
14 days
Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit
14 days
Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit
14 days
- +1 more secondary outcomes
Study Arms (3)
Loteprednol Etabonate Ophthalmic Gel dosed TID
EXPERIMENTALGel
Loteprednol Etabonate Ophthalmic Gel dosed BID
EXPERIMENTALGel
Vehicle Gel
PLACEBO COMPARATORVehicle
Interventions
Gel
Gel
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Valeant Site 01
Phoenix, Arizona, 85032, United States
Valeant Site 03
Oceanside, California, 92056, United States
Valeant Site 05
Miami, Florida, 33143, United States
Valeant Site 04
Quincy, Massachusetts, 02169, United States
Valeant Site 06
Kansas City, Missouri, 64111, United States
Valeant Site 02
St Louis, Missouri, 63131, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Manager
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Denise Ramjit
Valeant Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
June 1, 2016
Study Start
June 1, 2016
Primary Completion
June 13, 2017
Study Completion
July 1, 2017
Last Updated
January 8, 2021
Results First Posted
April 14, 2020
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share