UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002833 |
|---|---|
| Receipt number | 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 01:32:01 |
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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
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
caterina_gagliano@hotmail.com
Sponsor or person
Institute
UNIVERSITY OF CATANIA
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003458
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