An Interventional, Confirmative, Post Marketing Clinical Followup (PMCF) Study to Evaluate Performance and Safety of Ophthalmic Solutions Used to Relieve Dry Eyes Like Symptoms in Glaucoma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Evaluate the performance of Investigational Products to relieve symptoms of ocular surface disease in glaucoma patients. The performance will be evaluated by Shirmer I test at baseline (V0) and end of study visit (change will be assessed)
研究概览
简要总结
Study Rationale: The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells. These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve.
Degeneration of these nerves results in cupping, a characteristic appearance of the optic disc and visual loss. The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized. Glaucoma affects more than 70 million people worldwide with approximately 10% being bilaterally blind, making it the leading cause of irreversible blindness in the world. Glaucoma can remain asymptomatic until it is severe, resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it.
The tear film is fundamental in the maintenance of the ocular surface. Any condition that adversely affects the stability and function of the tear film such as dry eye symptom, blepharitis, and meibomian gland dysfunction, dysfunctional tear film syndrome, or toxicity of topical medications may result in onset of an ocular surface disease (OSD). The symptoms of OSD may include dryness, burning or stinging, itching, irritation, tearing, photophobia, foreign-body sensation, grittiness, redness, fatigue, fluctuating visual acuity, and blurred vision.
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age. OSD is seen in approximately 15% of the general elderly population and is reported in 48% to 59% of patients with medically treated glaucoma. One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment.
Ophthalmic solutions with soothing and refreshing proprieties, as addon treatment to glaucoma therapy, could relieve the OSD symptomatology, dry eye like, in glaucoma patients, improving their quality of life.
For these reasons, an interventional, confirmative, post marketing clinical followup (PMCF) study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients.
Study Objective: The objectives of this PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of three investigational products (IPs).
The IPs are on the market with the following brand names:
- Afomill Refreshing Soothing
- Afomill Anti-redness Eye Drops
- Iridil
详细描述
Study Rationale: The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells. These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve.
Degeneration of these nerves results in cupping, a characteristic appearance of the optic disc and visual loss. The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized. Glaucoma affects more than 70 million people worldwide with approximately 10% being bilaterally blind, making it the leading cause of irreversible blindness in the world. Glaucoma can remain asymptomatic until it is severe, resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it.
The tear film is fundamental in the maintenance of the ocular surface. Any condition that adversely affects the stability and function of the tear film such as dry eye symptom, blepharitis, and meibomian gland dysfunction, dysfunctional tear film syndrome, or toxicity of topical medications may result in onset of an ocular surface disease (OSD). The symptoms of OSD may include dryness, burning or stinging, itching, irritation, tearing, photophobia, foreign-body sensation, grittiness, redness, fatigue, fluctuating visual acuity, and blurred vision.
OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age. OSD is seen in approximately 15% of the general elderly population and is reported in 48% to 59% of patients with medically treated glaucoma. One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment.
Ophthalmic solutions with soothing and refreshing proprieties, as addon treatment to glaucoma therapy, could relieve the OSD symptomatology, dry eye like, in glaucoma patients, improving their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Informed consent form (ICF) signed;
- •M & F Aged ≥ 18 years at the time of the signature of ICF;
- •Patients with a prescription, as per clinical practice, of a topic treatment for glaucoma or ocular hypertension (i.e. anti-hypertensive eye drops), showing OSD symptoms (dry eye like symptoms; e.g. burning, redness, fatigue, or irritation sensation).
- •Willing not to use other eye drops during the entire treatment period (except for the possible drug-containing glaucoma treatment prescribed as per clinical practice).
排除标准
- •Other - different - eyes clinical conditions;
- •Retinal pathology;
- •Other type of ophthalmic neuropathy;
- •Severe POAG;
- •Known hypersensitivity or allergy to IP components;
- •Eye surgery during the previous 6 months (e.g. cataract surgery)
- •Presence of any relevant severe organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant in Investigator's opinion;
- •Participation in another investigational study;
- •Inability to follow all study procedures, including attending all site visits, tests and examinations;
- •Mental incapacity that precludes adequate understanding or cooperation.
结局指标
主要结局
Evaluate the performance of Investigational Products to relieve symptoms of ocular surface disease in glaucoma patients. The performance will be evaluated by Shirmer I test at baseline (V0) and end of study visit (change will be assessed)
时间窗: Day 0 (baseline visit the IP will be dispensed) and Day 30
To evaluate the performance of IPs to relieve symptoms of OSD (dry eye like symptoms, e.g. burning, redness, fatigue, or irritation sensation according the IFU) in glaucoma patients, the Shirmer I test (ST) might be completed at baseline (V0) and end of study visit (EOS/V2). The evaluation will be performed stratified by study IPs.
次要结局
- Evaluation of the maintenance of the basic condition of glaucoma by Intraocular pressure at baseline (V0) and end of study visit (change will be assessed)(Day 0 (baseline visit the IP will be dispensed) and Day 30)
- Evaluate the performance of Investigational Products to affect the tear film in glaucoma patients. The performance will be evaluated by Tear breakup time test at baseline (V0) and end of study visit (change will be assessed)(Day 0 (baseline visit the IP will be dispensed) and Day 30)
- Efficacy of Investigational Products used as intended to relieve symptoms of OSD in glaucoma patients. The Efficacy will be evaluated by Questionnaire at baseline (V0) and end of study visit (change will be assessed)(Day 0 (baseline visit the IP will be dispensed) and Day 30)
- To evaluate the safety and tolerability of the Investigational Products by Visual Analogue Scale at the end of study visit(Day 30)
- The patient satisfaction will be evaluated with a 5-points Likert Scale at the end of study visit(Day 30)