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

Study Overview
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Brief Summary
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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).

Official Title
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Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Monoprost
* Drug: Lumigan 0.01%
* Drug: Lumigan 0.03% Unit Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥18 years old. Written informed consent. Association of the 3 following criteria: 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). Intra Ocular Pressure ≤ 18 mm Hg in both eyes. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monoprost<br>1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. | Drug: Monoprost<br>* 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.<br>* Other names: Latanoprost 0.005%;|
| Active Comparator: Lumigan 0.01%<br>1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. | Drug: Lumigan 0.01%<br>* Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.<br>* Other names: Bimatoprost 0.1mg/ml;|
| Active Comparator: Lumigan 0.03% Unit Dose<br>1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. | Drug: Lumigan 0.03% Unit Dose<br>* Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.<br>* Other names: Bimatoprost 0.3mg/ML;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye | The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit. The conjunctival hyperaemia will be scored using the McMonnies photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia. The Rows represent the number of participants with a change from Baseline to D84 corresponding to decrease of 3 points decrease of 2 points no change, increase of 2 points increase of 1 point on Mc Monnies scale | Day 84 |