NCT00478036

Brief Summary

The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 7, 2016

Completed
Last Updated

October 7, 2016

Status Verified

August 1, 2016

Enrollment Period

6.7 years

First QC Date

May 23, 2007

Results QC Date

March 17, 2016

Last Update Submit

August 15, 2016

Conditions

Open Angle Glaucoma

Keywords

glaucomaselective laser trabeculoplastyanterior chamber flare

Outcome Measures

Primary Outcomes (1)

  • Interocular Pressure

    IOP, measured by Goldmann applanation tonometry

    8 weeks

Study Arms (3)

Acular LS

ACTIVE COMPARATOR

Acular LS - 1 drop in treated eye, 4 times a day, for 4 days

Drug: Acular LS

Pred Forte

ACTIVE COMPARATOR

Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days

Drug: Pred Forte

Refresh Tears

PLACEBO COMPARATOR

Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days

Other: Refresh Tears

Interventions

Acular LSDRUG

Details covered in arm description

Also known as: KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
Acular LS
Pred ForteDRUG

Details covered in arm description

Also known as: Prednisolone acetate ophthalmic suspension 1%
Pred Forte
Refresh TearsOTHER

Placebo

Also known as: CARBOXYMETHYLCELLULOSE SODIUM
Refresh Tears

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
  • Able to provide written informed consent to participate.
  • Must be the age of 18 years of age or older.
  • Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.

You may not qualify if:

  • Patients with eye surgery in the prior six months.
  • Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
  • Patients with pre-existing anterior chamber inflammation.
  • Patients with known sensitivity to any of the study medications.
  • Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

KetorolacKetorolac TromethamineOphthalmic Solutionsprednisolone acetateCarboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsMethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Malik Kahook, MD
Organization
University of Colorado, Dept. of Ophthalmology
Malik.kahook@ucdenver.edu
720-848-2501

Study Officials

  • Malik Y. Kahook, MD

    Rocky Mountain Lions Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 7, 2016

Results First Posted

October 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)