Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo

NCT01042665 | Completed DMC

• 1 other identifier: 20057259
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to evaluate the relationship between IOP fluctuation, RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.

Conditions

Glaucoma

Keywords

Glaucoma; intraocular pressure; latanoprost; retinal ganglion cell; pattern electroretinogram

Outcome Measures

Primary Outcomes (1)

• Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function

  RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)

  8 weeks

Study Arms (2)

primary open angle glaucoma

Patients with glaucomatous optic neuropathy defined as narrowing of the neuroretinal rim, notching, excavation, or RNFL defect; and repeatable standard automated perimetry abnormality defined as a glaucoma hemifield test (GHT) "outside normal limits" or pattern standard deviation (PSD) outside 95% normal limits were included.

Drug: latanoprost 0.005%; Drug: Placebo

Ocular Hypertensive group

Ocular hypertension defined as an intraocular pressure ≥ 24 mm Hg and ≤ 32 mm Hg in one eye and IOP ≥ 22 mm Hg and ≤ 32 mm Hg in the fellow eye, with normal optic disc, normal visual field defined as follows mean Deviation (MD) or Pattern Standard Deviation (PSD) of p\>5%, normal Glaucoma Hemifield Test (GHT) and reliable visual field exam

Drug: latanoprost 0.005%; Drug: Placebo

Interventions

latanoprost 0.005% DRUG

Active comparator

Also known as: Xalatan

Ocular Hypertensive group; primary open angle glaucoma

Placebo DRUG

Placebo comparator

Also known as: Inactive tear drops

Ocular Hypertensive group; primary open angle glaucoma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary open angle glaucoma or ocular hypertension from the Glaucoma Clinic at Bascom Palmer Eye Institute- Palm Beach Office.

You may qualify if:

• Ocular hypertension defined as an IOP ≥ 24 mm Hg and ≤ 32 mm Hg in one eye and IOP ≥ 22 mm Hg and ≤ 32 mm Hg in the fellow eye
• Normal optic disc
• Normal visual field defined as follows:
• Mean Deviation (MD) or Pattern Standard Deviation (PSD) of p\>5%
• Normal Glaucoma Hemifield Test (GHT)
• Reliable visual field exam (less than 33% false positives or false negatives, and less than 20% fixation losses)
• Glaucomatous visual field loss defined as a CPSD (p \< 0.05), or GHT (p \< 1%) outside normal limits with consistent with ONH or NFL defect
• Early visual field loss defined as MD ≤ -6.0 dB
• Untreated IOP ≤ 32 mmHg
• ONH or NFL defect defined as either inter-eye CDR asymmetry \> 0.2, rim thinning or notching, or NFL bundle defect visible on slitlamp biomicroscopy and stereo color fundus photography

You may not qualify if:

• Best-corrected visual acuity less than 20/40 either eye
• Abnormal or unreliable VF
• Untreated IOP \> 32 mmHg
• Age \< 18 or \>85 years
• Refractive error of \> +3.00 D or \< -7.00 D
• Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
• Need for chronic ocular or systemic corticosteroid use
• Narrow/closed angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
• Diabetic retinopathy
• Other diseases that may cause VF loss or optic disc abnormalities
• Life-threatening or debilitating illness making it unlikely patient could successfully complete the study
• Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
• Refusal of informed consent or of commitment to the full length of the study
• Contraindication to latanoprost or placebo vehicle
• Best-corrected visual acuity less than 20/40

Sponsors & Collaborators

• University of Miami: lead
• Pfizer: collaborator

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, 33418, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• David S Greenfield, MD

  University of Miami Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: February 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

US (1)