Evaluation of the tolerance and efficacy of Monoprost in patients with Glaucoma or Ocular Hypertension, stabilized by all prostaglandin (except Monoprost®) with signs of ocular surface intolerance.

Phase 1

• Conditions: glaucoma, ocular hypertension; MedDRA version: 18.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2013-001250-10-DE
• Lead Sponsor: aboratoires Thea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-30
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

Patients will be eligible for inclusion if all these criteria are respected:

[1.1]Male or female aged =18 years old.

[1.2]Written informed consent.

[1.3]Association of the 3 following criteria:
[1.3.1] Both eyes have been treated and controlled for at least three months with monotherapy of all prostaglandin (except Monoprost®), and have a diagnosis of one of the following:
•Primary Open Angle Glaucoma or OHT
•Exfoliative glaucoma or OHT with exfoliative syndrome
•Pigmentary glaucoma or OHT with pigment dispersion syndrome
[1.3.2] IOP = 18 mm Hg in BOTH eyes.
[1.3.3]With local intolerance signs in at least one eye defined by the association of:
[1.3.3.1]Hyperaemia = Grade (2) or (3) or (4) following the photographic McMonnies scale (0 to 5).
And
[1.3.3.2.1]Presence of at least 2 symptoms with a level of severity = 1 (= mild or moderate or severe) among the following 5 symptoms: irritation / burning, itching, tearing, eye dryness sensation, foreign body sensation.
And/Or
[1.3.3.2.2]Presence of at least 2 signs with a level of severity = 1 (= mild or moderate or severe) among the following 3 signs: superficial punctate keratitis, blepharitis, eyelid skin darkness.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

Exclusion Criteria

Ophthalmic exclusion criteria (in either eye) [2.1]

[2.1.1]Presence of at least one severe objective sign among the following:
[2.1.1.1]Global ocular staining with Oxford (0-15) grading scheme >12.
[2.1.1.2]Blepharitis (Grade 4: very severe, i.e. Eczematiform lesion).
[2.1.2]Any secondary glaucoma/OHT (except when associated with exfoliative syndrome or pigment dispersion syndrome), any congenital glaucoma or any angle-closure glaucoma/OHT.
[2.1.3] Visual field not performed or not available within the 6 months before inclusion visit.
[2.1.4]Fundus not performed or not available within the 6 months before inclusion visit.
[2.1.5]Advance stage of glaucoma:
[2.1.5.1]Absolute defect in the 10 degrees central point of the visual field.
[2.1.5.2]Severe visual field loss according to the investigator’s best judgement.
[2.1.5.3]Risk of visual field worsening as a consequence of participation in the trial according to the investigator’s best judgement.
[2.1.6]Best far corrected visual acuity = 1/10.
[2.1.7]History of traumatism, infection, inflammation within the 3 months before inclusion visit.
[2.1.8]Ongoing or known history of ocular allergy and/or uveitis and / or viral infection.
[2.1.9]Severe dry eye (defined by severe epithelial erosions of the cornea and / or use of dry eye medication with a frequency exceeding 8 instillations / day).
[2.1.10]Corneal ulceration.
[2.1.11]Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
[2.1.12]Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.
[2.1.13] Non-responder to latanoprost according to the medical history.

The protocol also defines other exclusion criteria such as systemic/non ophthalmic exclusion criteria, specific exclusion criteria for women, exclusion criteria related to general conditions and exclusion criteria related to previous and concomitant medications / non-product therapies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified