NCT00521456

Brief Summary

This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2007

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 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

August 23, 2007

Results QC Date

August 19, 2009

Last Update Submit

September 29, 2009

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (1)

  • Resolution of Post Operative Inflammation

    Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)

    Day 14

Secondary Outcomes (2)

  • Ocular Pain

    Day 1

  • Mean Pupil Area

    Day 0

Study Arms (2)

1

EXPERIMENTAL
Drug: ketorolac eye drops

2

PLACEBO COMPARATOR
Drug: ketorolac eye drops

Interventions

ketorolac eye dropsDRUG

1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo

12

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing cataract surgery

You may not qualify if:

  • Uncontrolled ocular disease in cataract surgery eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

Related Publications (1)

  • Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.

    PMID: 21145532DERIVED

Related Links

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan, Inc.
clinicaltrials@allergan.com
(714)246-4500

Study Officials

  • Medical Director

    Allergan

    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

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 27, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 1, 2009

Results First Posted

October 1, 2009

Record last verified: 2009-08

Locations

US(1)