Evaluation of the tolerance and efficacy of Monoprost in patients with Glaucoma or Ocular Hypertension, stabilized with Lumigan with signs of ocular surface intolerance

• 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-FR
• Lead Sponsor: aboratoires Thea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-25
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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]Signed and dated informed consent.

[1.3]Association of the 3 following criteria:
[1.3.1] Both eyes have primary open angle glaucoma or ocular hypertension, already treated and controlled by mono-therapy of Lumigan® 0.01% since at least 3 months (according to European Glaucoma Society guidelines).*.
[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.

*Chronic, progressive optic neuropathies, that have in common characteristics morphological changes at the optic nerve head and retinal nerve fibre layer in the absence of other ocular disease or congenital anomalies. Progressive retinal ganglion cells death and visual field loss are associated with these changes”

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 ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
[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.

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