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

Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01042665

Enrollment

Registered

2010-01-05

Start date

2006-02-28

Completion date

2009-12-31

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

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

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.

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.

Interventions

DRUGlatanoprost 0.005%

Active comparator

DRUGPlacebo

Placebo comparator

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function	8 weeks	RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026