Back to resultsLoteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Primary Purpose
Inflammation, Pain, Cataract
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Loteprednol Etabonate Gel (BID)
Loteprednol Etabonate Gel (TID)
Vehicle (BID)
Vehicle (TID)
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
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 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.
Sites / Locations
- Bausch & Lomb Incorporated
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Loteprednol Etabonate Gel (BID)
Vehicle (BID)
Loteprednol Etabonate Gel (TID)
Vehicle (TID)
Arm Description
Loteprednol Etabonate Gel 0.38% administered two times daily (BID).
Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID).
Loteprednol Gel 0.38% administered three times daily (TID).
Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
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 by Visit.
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.
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.
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
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).
Full Information
NCT ID
NCT01996839
First Posted
November 22, 2013
Last Updated
September 2, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01996839
Brief Title
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official Title
Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
Detailed Description
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
514 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loteprednol Etabonate Gel (BID)
Arm Type
Experimental
Arm Description
Loteprednol Etabonate Gel 0.38% administered two times daily (BID).
Arm Title
Vehicle (BID)
Arm Type
Active Comparator
Arm Description
Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID).
Arm Title
Loteprednol Etabonate Gel (TID)
Arm Type
Experimental
Arm Description
Loteprednol Gel 0.38% administered three times daily (TID).
Arm Title
Vehicle (TID)
Arm Type
Active Comparator
Arm Description
Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID).
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate Gel (BID)
Other Intervention Name(s)
Lotemax
Intervention Description
One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate Gel (TID)
Other Intervention Name(s)
Lotemax
Intervention Description
One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle (BID)
Other Intervention Name(s)
Vehicle
Intervention Description
One drop of vehicle instilled into the study eye two times per day (BID) for 14 days
Intervention Type
Drug
Intervention Name(s)
Vehicle (TID)
Other Intervention Name(s)
Vehicle
Intervention Description
One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
Description
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.
Time Frame
8 days
Title
Percentage of Participants With Grade 0 Pain in the Study Eye.
Description
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.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Description
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.
Time Frame
18 days
Title
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Description
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.
Time Frame
18 days
Title
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Description
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.
Time Frame
18 days
Title
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Description
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).
Time Frame
18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon I Williams, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
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