glaucoma, ocular hypertension MedDRA version: 17.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Monoprost®
Product Name: Latanoprost
Product Code: LT2345
Pharmaceutical Form: Eye drops, solution in single-dose container
Sponsors
Laboratoires Thea
Eligibility
Sex/Gender
All
Inclusion 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). 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% UD in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84. The conjunctival hyperaemia will be scored using the photographic McMonnies scale (0 to 5). The worse eye is defined as the eligible eye with the highest hyperaemia score on the McMonnies scale at D0. ; Secondary Objective: The secondary objective is to demonstrate the non-inferiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% UD in term of response to treatment in the worse eye at D84 defined as: • Mean IOP = 18 mm Hg And • Conjunctival hyperaemia decrease: reduction of at least 1 point on the McMonnies score compared to the score at the inclusion. ; Primary end point(s): Assessment of the change from baseline of conjunctival hyperaemia assessed on MacMonnies’ 6 point ordinal scale, in the worse eye at the D84 visit. The primary endpoint is a safety variable. The primary analysis will be in the mSAF set. ;Timepoint(s) of evaluation of this end point: Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 84; Secondary end point(s): Response to treatment in the worse eye at the D84 visit defined as: Mean IOP = 18 mm Hg and Decrease from baseline of at least 1 point in conjunctival hyperaemia assessed on MacMonnies’ 6 point ordinal scale. The major secondary endpoint is a variable combining efficacy and safety. Although it is a combined endpoint it is mainly considered as an efficacy variable, and therefore the primary assessment will be in the mITT set. | — |
Countries
France, Germany, Greece, Spain, United Kingdom
Contacts
Public ContactDépartement clinique
Laboratoires Thea
Outcome results
None listed