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

NCT01042665

Last updated date
Study Location
University of Miami Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo
Official Title Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo
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.

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Glaucoma
Intervention
  • Drug: latanoprost 0.005%
    Active comparator
    Other Name: Xalatan
  • Drug: Placebo
    Placebo comparator
    Other Name: Inactive tear drops
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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
    Interventions:
    • Drug: latanoprost 0.005%
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2010)
82
Original Actual Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01042665
Other Study ID Numbers 20057259
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David S. Greenfield, University of Miami
Study Sponsor University of Miami
Collaborators Pfizer
Investigators
Principal Investigator:David S Greenfield, MDUniversity of Miami Bascom Palmer Eye Institute
PRS Account University of Miami
Verification Date March 2014