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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002833
Receipt No. R000003458
Scientific Title Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study
Date of disclosure of the study information 2009/12/03
Last modified on 2009/12/03

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Basic information
Public title Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study
Acronym Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study
Scientific Title Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study
Scientific Title:Acronym Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study
Region
Europe

Condition
Condition GLAUCOMA
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the role of Palmitoylethanolamide (PEA) to reduce Intraocular Pressure value in patients with ocular hypertension (OHT) and primary open angle glaucoma (POAG).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the role of Palmitoylethanolamide (PEA) to reduce Intraocular Pressure value in patients with ocular hypertension (OHT) and primary open angle glaucoma (POAG).
Key secondary outcomes Evaluate visual acuity, visual fields, vital signs and psycotropic effects.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Palmytoilethanolamide (Visimast) oral admistration 300mg twice daily./ At baseline and the following examinations the following parameters were evaluated: best corrected visual acuity, biomicroscopic and slit-lamp and dilated funduscopic examinations with evaluation of vertical and horizontal cup-dik ratio, measurement of IOP. Centracorneal tickness measurement and visual field test were performed at the beginning and at the end of the two periods ofthe two periods of the study.
Interventions/Control_2 Placebo oral administration twice daily./
At baseline and the following examinations the following parameters were evaluated: best corrected visual acuity, biomicroscopic and slit-lamp and dilated funduscopic examinations with evaluation of vertical and horizontal cup-dik ratio, measurement of IOP. Centracorneal tickness measurement and visual field test were performed at the beginning and at the end of the two periods ofthe two periods of the study.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients aged 18-70 years, affected by primary open angle glaucoma with ocular hypertension under control with hypotonic drug (<18mmHg).
2. Visual field defects and optic disc cupping for at least one year (with at least 2 following exams).
3. All patients should be able to perform a reliable visual field (a minimum of 5 tests).
Key exclusion criteria 1. Advanced stage glaucoma
2. Smokers
3. No tolerability to product under evaluation
4. Needs of glaucoma surgical or laser therapy
5. Ocular surgery in the last year
6. Visual acuity lower < 8/10 with refractive error > 3 diopters
7. Pupillary diameter < 2.5mm
8. Concomitant systemic or ocular pathologies
9. Pregnant or lactation
10. Vasoactive systemic therapies (Ca- antagonistis, oral betablokers, others)
11 Partecipation to other trials


Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name CATERINA GAGLIANO
Organization UNIVERSITY OF CATANIA
Division name OPHTHALMOLOGY DEPERTMENT
Zip code
Address VIA G. CLEMENTI 36
TEL 3472698035
Email

Public contact
Name of contact person
1st name
Middle name
Last name CATERINA GAGLIANO
Organization UNIVERSITY OF CATANIA
Division name OPHTHALMOLOGY DEPERTMENT
Zip code
Address VIA G. CLEMENTI 36
TEL 3472698035
Homepage URL
Email caterina_gagliano@hotmail.com

Sponsor
Institute UNIVERSITY OF CATANIA
Institute
Department

Funding Source
Organization PUBLIC
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Italy

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The cannabimimetic agent PEA orally administered (300 mg tablets-Visimast) twice daily was able to significantly reduce IOP after 1 month as well as 2 month therapy in primary open angle glaucoma patients which were under topical anti-hypertensive drug treatment.      
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information the PEA was well tolereted and safe. No side effects were reported in PEA treatment group.

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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