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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David S. Greenfield, University of Miami
ClinicalTrials.gov Identifier:
NCT01042665
First received: January 4, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Glaucoma
Drug: latanoprost 0.005%
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)


Enrollment: 82
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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%
Active comparator
Other Name: Xalatan
Drug: Placebo
Placebo comparator
Other Name: Inactive tear drops
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%
Active comparator
Other Name: Xalatan
Drug: Placebo
Placebo comparator
Other Name: Inactive tear drops

Detailed Description:

It has been hypothesized that intraocular (IOP) variability is an independent risk factor for the progression of glaucoma. IOP variability includes 24 hour IOP fluctuation during the waking period (diurnal fluctuation) and sleep period (nocturnal fluctuation) as well as longitudinal IOP variability measured in the diurnal period over the course of multiple office visits.

Latanoprost has been clinically used to lower eye pressure in glaucoma and ocular hypertension for almost 10 years. Latanoprost 0.005% has been demonstrated to provide superior ocular hypotensive efficacy compared with timolol 0.5% in pivotal phase 3 clinical trials (Alm et al. 1995; Camras 1996).

The Pattern Electroretinogram (PERG) is a non-invasive technology that objectively measures the retinal ganglion cell (RGC) function (Porciatti and Ventura 2004). A recent study has demonstrated that the RGC function can be improved following IOP reduction in glaucomatous eyes with early visual field defects (Ventura and Porciatti 2005).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

Inclusion Criteria - OHT:

  • 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)

Inclusion Criteria - POAG:

  • 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

Exclusion Criteria:

Exclusion Criteria - OHT:

  • 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

Exclusion criteria - POAG:

  • Best-corrected visual acuity less than 20/40
  • 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
  • Diabetic retinopathy
  • Other diseases that may cause VF loss or optic disc abnormalities
  • Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
  • Inability to perform reliably on automated VF testing
  • Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
  • Refusal of informed consent or of commitment to the full length of the study
  • Contraindication to latanoprost or placebo vehicle
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042665

Locations
United States, Florida
University of Miami Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418
Sponsors and Collaborators
University of Miami
Pfizer
Investigators
Principal Investigator: David S Greenfield, MD University of Miami Bascom Palmer Eye Institute
  More Information

No publications provided

Responsible Party: David S. Greenfield, Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT01042665     History of Changes
Other Study ID Numbers: 20057259
Study First Received: January 4, 2010
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Glaucoma
intraocular pressure
latanoprost
retinal ganglion cell
pattern electroretinogram

Additional relevant MeSH terms:
Synovial Cyst
Ganglion Cysts
Glaucoma
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014