GlaucomaNCT01042665
Relationship Between Eye Pressure and Ganglion Cell Function in Eyes Receiving Latanoprost Versus Placebo
An observational study of Glaucoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- latanoprost 0.005%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary open angle glaucoma or ocular hypertension from the Glaucoma Clinic at Bascom Palmer Eye Institute- Palm Beach Office.
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418
About this study
Official title: Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- latanoprost 0.005%, Placebo
- Keywords
- Glaucoma, intraocular pressure, latanoprost, retinal ganglion cell, pattern electroretinogram
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latanoprost 0.005%Drug
Also called Xalatan
Active comparator
PlaceboDrug
Also called Inactive tear drops
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: latanoprost 0.005%; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function
RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, David S. Greenfield, University of Miami
- Investigators
- David S Greenfield, MD, Principal investigator, University of Miami Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042665
- Sponsor's protocol ID
- 20057259
- Status last verified
- Mar 2014
- First submitted
- 4 Jan 2010
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo
- ClinicalTrials.gov ID
- NCT01042665
- Acronym / sponsor ID
- 20057259
- Conditions
- Glaucoma
- Keywords
- Glaucoma, intraocular pressure, latanoprost, retinal ganglion cell, pattern electroretinogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary open angle glaucoma | – | Drug: latanoprost 0.005%, Drug: PlaceboPatients 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. |
| Ocular Hypertensive group | – | Drug: latanoprost 0.005%, Drug: PlaceboOcular 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary open angle glaucoma or ocular hypertension from the Glaucoma Clinic at Bascom Palmer Eye Institute- Palm Beach Office.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| latanoprost 0.005%Also: XalatanActive comparator | Drug | Ocular Hypertensive group, primary open angle glaucoma |
| PlaceboAlso: Inactive tear dropsPlacebo comparator | Drug | Ocular Hypertensive group, primary open angle glaucoma |
Primary outcome
Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function
Time frame: 8 weeks
RGC function is evaluated by pattern electroretinogram optimized for glaucoma (PERGLA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Greenfield, MD principal investigator
University of Miami Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of impact of intraocular (IOP) reduction on retinal ganglion cell (RGC) function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.