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Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study

Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study - Ocular Hypotensive Efficacy and Safety of oral Palmytoilethanolamide (Visimast): Clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002833
Enrollment
42
Registered
2009-12-03
Start date
2008-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GLAUCOMA

Interventions

Palmytoilethanolamide (Visimast) oral admistration 300mg twice daily./ At baseline and the following examinations the following parameters were evaluated: best corrected visual acuity, biomicroscopic

Sponsors

UNIVERSITY OF CATANIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Evaluate the role of Palmitoylethanolamide (PEA) to reduce Intraocular Pressure value in patients with ocular hypertension (OHT) and primary open angle glaucoma (POAG).

Secondary

MeasureTime frame
Evaluate visual acuity, visual fields, vital signs and psycotropic effects.

Countries

Europe

Contacts

Public ContactCATERINA GAGLIANO

UNIVERSITY OF CATANIA OPHTHALMOLOGY DEPERTMENT

caterina_gagliano@hotmail.com3472698035

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026