EUCTR2013-001250-10-GBActive, not recruitingPhase 1
Safety and Efficacy assessment of Monoprost® (unpreserved latanoprost) in comparison with Lumigan® 0.01 % and Lumigan® 0.03% UD, in patients with open angle glaucoma or ocular hypertension, stabilized by Lumigan® 0.01 % or Xalatan® with ocular surface intolerance. Phase IV, international, multicentre, randomised, investigator masked, 3 months duration, 3 parallel groups, 3 X 120 evaluable patients
aboratoires Thea0 sites396 target enrollmentStarted: July 19, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 396
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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 been treated and controlled for at least three months with monotherapy of EITHER Lumigan® 0.01% or Xalatan®, 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).
- •[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.
- •[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 Xalatan® 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.
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