NCT02208297

Brief Summary

The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

August 1, 2014

Results QC Date

August 18, 2020

Last Update Submit

September 2, 2020

Conditions

InflammationPainCataract

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 (2)

Loteprednol Etabonate Gel (BID)

EXPERIMENTAL

Loteprednol Etabonate Gel 0.38% administered two times daily (BID)

Drug: Loteprednol Etabonate Gel (BID)

Vehicle Gel (BID)

PLACEBO COMPARATOR

Vehicle gel administered two times daily (BID)

Drug: Vehicle Gel (BID)

Interventions

Loteprednol Etabonate Gel (BID)DRUG

One drop of LE gel instilled into the study eye two times per day (BID) for 14 days

Also known as: Lotemax
Loteprednol Etabonate Gel (BID)
Vehicle Gel (BID)DRUG

One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days

Also known as: Vehicle
Vehicle Gel (BID)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 intraocular lens (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

Location

MeSH Terms

Conditions

InflammationPainCataract

Interventions

BID protein, humanLoteprednol Etabonate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsLens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Jason Vittitow

    Valeant/Bausch & Lomb

    STUDY DIRECTOR

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

August 1, 2014

First Posted

August 5, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 25, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)