Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose

This is an interventional treatment trial for Primary Open Angle Glaucoma Read More

Inclusion Criteria:

• Male or female aged ≥18 years old.
• Written informed consent.

• Association of the 3 following criteria:

  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).
  2. Intra Ocular Pressure ≤ 18 mm Hg in both eyes.
  3. With local intolerance signs in at least one eye defined by the association of:

3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale.

And 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 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.

Exclusion Criteria:

• - Presence of at least one severe objective sign among the following:

  • Global ocular staining with Oxford (0-15) grading scheme >12.
  • Blepharitis (Grade 4: Very severe, i.e. eczematiform lesion).
• Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
• Visual field not performed or not available within the 6 months before inclusion visit.
• Fundus not performed or not available within the 6 months before inclusion visit.

• Advanced stage of glaucoma:

  • Absolute defect in the ten degrees central point of the visual field.
  • Severe visual field loss according to the investigator's best judgement.
  • Risk of visual field worsening as a consequence of participation in the trial according to the investigator's best judgement.
• Best far corrected visual acuity ≤ 1/10.
• History of trauma, infection, inflammation within the 3 months before inclusion visit.
• Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
• 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).
• Corneal ulceration.
• Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
• Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.

Systemic/non ophthalmic/ exclusion criteria

• Non-controlled diabetic patient.
• Known or suspected hypersensitivity to one of the components of the study product.
• Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.

Specific exclusion criteria for women

• Pregnancy, lactation.
• Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) and is not surgically sterilised.