NCT00956462

Brief Summary

This study aims to evaluate the eye pressure response to non-steroidal anti-inflammatory eye drops as compared to steroid eye drops following glaucoma surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 11, 2009

Status Verified

July 1, 2009

Enrollment Period

2.4 years

First QC Date

July 17, 2009

Last Update Submit

August 7, 2009

Conditions

Glaucoma

Keywords

intraocular pressureAhmed valveNSAIDSsteroids

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Six weeks

Study Arms (2)

NSAID

EXPERIMENTAL
Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Steroids

ACTIVE COMPARATOR
Drug: Ketorolac (NSAID) versus Dexamethasone (steroid)

Interventions

Ketorolac (NSAID) versus Dexamethasone (steroid)DRUG

Topical NSAID versus topical steroid after implantation of glaucoma drainage device

Also known as: Acular (NSAID), Maxidex (steroid)
NSAIDSteroids

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Undergoing glaucoma drainage device surgery

You may not qualify if:

  • Unable to consent
  • Undergoing combined GDD and cataract surgery
  • Patients with conditions requiring additional anti-inflammatory medications e.g., uveitic glaucoma, previous corneal transplant
  • Patients with prior history of corneal ulceration
  • Breast-feeding (nursing) mothers
  • Pregnant or planning to become pregnant during the trial period
  • Allergic to Ketorolac Tromethamine, or had an allergic-type reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs used for pain relief or arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graham Trope

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

KetorolacAnti-Inflammatory Agents, Non-SteroidalSteroidsKetorolac TromethamineDexamethasone

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroids, Fluorinated

Study Officials

  • Graham Trope, MD FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham E Trope, Professor

CONTACT

416-603-5317Graham.Trope@uhn.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

August 11, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 11, 2009

Record last verified: 2009-07

Locations

CA(1)