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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- Presence of at least one severe objective sign among the following:
- •Global ocular staining with Oxford (0-15) grading scheme >
- •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/
- •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.
研究组 & 干预措施
Monoprost
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
干预措施: Monoprost (Drug)
Lumigan 0.01%
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
干预措施: Lumigan 0.01% (Drug)
Lumigan 0.03% Unit Dose
1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.
干预措施: Lumigan 0.03% Unit Dose (Drug)
结局指标
主要结局
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
时间窗: Day 84
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
次要结局
未报告次要终点