Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
1 other identifier
interventional
514
1 country
1
Brief Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2013
Shorter than P25 for phase_3
1 active site
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
November 22, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
September 3, 2020
CompletedSeptember 25, 2020
September 1, 2020
5 months
November 22, 2013
August 18, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
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.
8 days
Percentage of Participants With Grade 0 Pain in the Study Eye.
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.
8 days
Secondary Outcomes (4)
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
18 days
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
18 days
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
18 days
Study Arms (4)
Loteprednol Etabonate Gel (BID)
EXPERIMENTALLoteprednol Etabonate Gel 0.38% administered two times daily (BID).
Vehicle (BID)
ACTIVE COMPARATORVehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID).
Loteprednol Etabonate Gel (TID)
EXPERIMENTALLoteprednol Gel 0.38% administered three times daily (TID).
Vehicle (TID)
ACTIVE COMPARATORVehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).
Interventions
One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
One drop of vehicle instilled into the study eye two times per day (BID) for 14 days
One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
Eligibility Criteria
You may qualify if:
- 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 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.
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.
- Have known hypersensitivity or contraindication to the study drug(s) or their components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb Incorporated
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Jon I Williams, PhD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2013
First Posted
November 27, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
September 25, 2020
Results First Posted
September 3, 2020
Record last verified: 2020-09