NCT01010633

Brief Summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2009

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

Study Start

First participant enrolled

November 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 9, 2012

Completed
Last Updated

January 9, 2012

Status Verified

December 1, 2011

Enrollment Period

7 months

First QC Date

November 6, 2009

Results QC Date

August 30, 2011

Last Update Submit

December 8, 2011

Conditions

InflammationPain

Outcome Measures

Primary Outcomes (2)

  • Resolution of Anterior Chamber Cells (ACC).

    Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.

    Visit 5 (Postoperative day 8)

  • Grade 0 Pain

    Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

    Visit 5 (Postoperative Day 8)

Secondary Outcomes (1)

  • Resolution of Anterior Chamber Cells.

    At visits 4-7- postoperative day 3, 8,15 & 18

Study Arms (2)

Loteprednol Etabonate

EXPERIMENTAL

Loteprednol etabonate

Drug: Loteprednol Etabonate

Vehicle

PLACEBO COMPARATOR

Vehicle of loteprednol etabonate

Drug: Vehicle of Loteprednol Etabonate

Interventions

Vehicle of Loteprednol EtabonateDRUG

1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.

Vehicle
Loteprednol EtabonateDRUG

1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Loteprednol Etabonate

Eligibility Criteria

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

You may qualify if:

  • Subjects who are at least 18 years of age.
  • Subjects who are candidates for routine, uncomplicated cataract surgery.
  • Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

You may not qualify if:

  • Subjects who have known hypersensitivity or contraindication to the study drug or components.
  • Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
  • Subjects with elevated intraocular pressure (\>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
  • Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb, Inc.

Rochester, New York, 14609, United States

Location

Related Publications (1)

  • Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.

    PMID: 24136301DERIVED

MeSH Terms

Conditions

InflammationPain

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Tuyen Ong, MD, MRCOphth
Organization
Bausch & Lomb Incorporated
tuyen.ong@bausch.com
(973) 360-6389

Study Officials

  • Laura Trusso

    Bausch & Lomb Incorporated

    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

November 6, 2009

First Posted

November 10, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

January 9, 2012

Results First Posted

January 9, 2012

Record last verified: 2011-12

Locations

US(1)