Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Monoprost; Lumigan 0.01%; Lumigan 0.03% Unit Dose
Intervention description: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.; Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.; Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Intervention MeSH terms: Bimatoprost; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 379.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary objective:

      The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01%
      and Lumigan® 0.03% Unit Dose 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 MacMonnies photographic scale (0 to 5).
    

Eligibility criteria:

        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.