Condition category
Eye Diseases
Date applied
05/09/2011
Date assigned
19/09/2011
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mauro Cellini

ORCID ID

Contact details

Via Palagi 9
Bologna
40138
Italy
mauro.cellini@unibo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/2009/U/DISP

Study information

Scientific title

Palmitoylethanolamide intake and systemic endothelial function in ocular hypertensive patients: a single centre, randomized double blind, placebo controlled cross-over study

Acronym

Study hypothesis

Glaucoma is a multi-factorial optic neuropathy of unknown aetiology in which the increased intraocular pressure is the most important risk factor, but also ischaemia, vascular dysregulation, vasospasm and endothelial dysfunction, may prevent the physiological regulation of ocular blood flow, determining modifications in the optic nerve head supply, contributing to the damage of the ganglion cells.

Therapeutically, therefore, both reducing intra ocular pressure (IOP) and improving ocular blood flow may be considered as treatment options both in glaucoma and ocular hypertension. It’s feasible that ameliorating endothelial function may contribute to improve optic nerve head blood supply and to reducing susceptibility of Orthotopic heart transplantation (OHT) patients to develop glaucoma or of glaucoma patients to progress more rapidly.

Palmitoylethanolamide belongs to the endocannabinoid system and it is implicated in the physiology of different human systems, included ocular tissues and vascular system where seems to exert, among others, an important role in the endothelial protection in the rat so it could play a main role in the treatment of glaucoma or OHT patients.

Ethics approval

Local Ethics Committee of the S. Orsola-Malpighi Hospital, Bologna, 5 September 2010, ref: C/2009/U/DISP

Study design

Single centre randomized double blind placebo controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ocular hypertension

Intervention

Treatment arms: 20 OHT patients randomly assigned to assume a 300 mg oral tablet of palmitoylethanolamide (PEA) two time a day for three months and after two months of wash out switched to treatment with placebo. The others 20 OHT patients randomly assigned to assume placebo and after two months of wash out switched to treatment with palmitoylethanolamide (PEA).

All patients underwent:
1. Ophthalmologic examination including visual acuity and applanation IOP assessment
2. Corneal thickness evaluation with a Tomey SP3000 pachymeter (Tomey Corp., Nagoya, Japan)
4. Biomicroscopy of the anterior and posterior segment with automatic measurement of the C/D area ratio of the optic nerve head with Stratus OCT3 (Zeiss-Humphrey, Dublin, CA).
5. Standard achromatic perimetry (SAP) with a Humphrey Field Analyzer-SITA program (Zeiss-Humphrey, San Leandro, CA)
6. Blood sampling to assess lipid profile and fasting serum glucose.
7. Body mass index calculation
8. Systolic and diastolic blood pressure measurement
9. Assessment of the flow-mediated vasodilatation (FMD) with a Philips ENVISOR echographic machine (Philips Medical Systems, Best, The Netherlands); FMD was calculated as the percentage change in brachial artery diameter in response to reactive hyperemia:
FMD = [(VDHyperemia – VDBaseline)/ VDBaseline] x 100%
VD= Vessel Diameter

Intervention type

Drug

Phase

Not Specified

Drug names

Palmitoylethanolamide

Primary outcome measures

1. FMD values in OHT patients compared with controls at baseline
2. FMD values in OHT patients randomly assigned to assume Palmitoylethanolamide or placebo for 3 months
3. FMD values in OHT patients after 2 month washout period
4. FMD values in OHT patients after they switched to the other treatment for further 3 months

Secondary outcome measures

Effect of palmitoylethanolamide vs placebo on the endothelial function of OHT patients at baseline, after treatment and wash-out

Overall trial start date

28/09/2010

Overall trial end date

10/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 40 patients aged < 65 years (mean 56.8±8.1)
2. Baseline IOP >= 22 mm/Hg, on at least two measurements (mean 23.11±0.93)
3. Open anterior chamber angle at gonioscopy, cup/disc ratio < 0.4
4. Normal visual field (VF) (MD <3 dB and PSD < 2.5 dB) and corneal central thickness within normal values
5. 40 healthy control subjects aged matched (mean 56.2±10.4)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 OHT patients and 40 healthy controls subjects

Participant exclusion criteria

1. Cardiovascular disease
2. Diabetes, hypertension, hypercholesterolemia
3. Vasoactive medications

Recruitment start date

28/09/2010

Recruitment end date

10/07/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Via Palagi 9
Bologna
40138
Italy

Sponsor information

Organisation

University of Bologna (Italy)

Sponsor details

Ophthalmology Service
Via Palagi 9
Bologna
40138
Italy

Sponsor type

University/education

Website

http://www.eng.unibo.it/PortaleEn/default.htm

Funders

Funder type

University/education

Funder name

University of Bologna (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23307959

Publication citations

  1. Results

    Strobbe E, Cellini M, Campos EC, Effectiveness of palmitoylethanolamide on endothelial dysfunction in ocular hypertensive patients: a randomized, placebo-controlled cross-over study., Invest. Ophthalmol. Vis. Sci., 2013, 54, 2, 968-973, doi: 10.1167/iovs.12-10899.

Additional files

Editorial Notes