A Prospective, Multi-center, Controlled, Double-blind Study to Evaluate the Efficacy and Tolerability of a Steroid/Antibiotic Associated Treatment Following Cataract Extraction by Means of Phaco-emulsification
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 180
- 试验地点
- 7
- 主要终点
- Measurement of inflammation conditions in the anterior ocular chamber after cataract extraction through Slit Lamp and Bio-microscopy.
研究概览
简要总结
Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success.
Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation.
After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative.
NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time.
The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
详细描述
Cataract is an ophthalmic disease that usually affects the elderly population. Therapy is surgical and during the past decades, improvements in surgical techniques and instruments have dramatically increased the number of cataract extractions performed.
With improvements in surgical techniques, Patients' expectations have risen proportionally; however, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world.
The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success.
Ocular inflammation, commonly observed after cataract surgery, is associated with a breakdown of the blood-aqueous barrier (BAB) as a result of surgical trauma-induced prostaglandin production.
Anterior chamber ocular inflammation, clinically assessed as anterior chamber cell counts and flare, is also common following cataract surgery. However, post-surgery inflammation is frequently viewed as an acceptable risk that is largely outweighed by the numerous benefits of cataract surgery.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
All daily study products will be manufactured in indistinguishable single dose plastic vials, labeled in accordance with hour of administration. In accordance with the double-blind design of the study, daily treatment for patients randomized to group A (NETILDEX™ ophthalmic gel), will be of 2 doses of active treatment and 2 doses of indistinguishable placebo. For blinding purposes, Group B (NETILDEX™ eye drops solution) medications labels will consist in an aluminum envelope for each dose of the daily treatment, containing indistinguishable plastic vials of NETILDEX™ eye drops solution. Tertiary packaging (patient's treatment supply) will be a carton box appropriately labeled, containing 16 secondary packages (aluminum envelopes - each envelope containing 5 vials for each treatment time dose), containing enough plastic vials to allow the patient to complete the whole study treatment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Patients
- •Patients aged ≥ 40 years old
- •Patients undergoing cataract extraction surgery through phaco-emulsification and intra-ocular lens implantation
- •Patients with grade 2 or 3 according to LOCS III system for grading age-related cataract
- •Patients with transparent cornea (endothelial count in the limits for age but not lower than 1200 cells/mm2)
- •Patients understanding the nature of the study and providing their informed consent to participation
- •Patients willing and able to attend the visits and procedures foreseen by study protocol
- •Patients with negative Amsler Test at enrolment visit (V1)
排除标准
- •Patients with medical history of ocular inflammation diseases, Herpes infections, iritis, uveitis or Sjogren's syndrome
- •Patients who have been treated for external ocular infections within a month before the study enrolment (V1)
- •Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm)
- •Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate)
- •Patients with at least one of the following concomitant ocular diseases: ocular infections, uveitis, iritis, iridociclitis, glaucoma, diabetic retinopathy, diabetes, maculopathy, shallow anterior chamber (based on Investigator's judgment)
- •Patients with PEX Syndrome (Pseudo-exfoliation syndrome)
- •Patients with poor mydriasis, basing on Investigator's judgment
- •Patients with intra-ocular pressure > 24 mmHg
- •Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1)
- •Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1)
- •Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids
- •Patients with traumatic cataract condition
- •Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1)
- •Patients who have received treatment with anti-histamines, decongestants, anti-inflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1). Bromfenac, only, will be allowed for 3 days before cataract surgery
- •Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1)
- •Patients receiving any ocular treatment, with the exception of artificial tears
- •Female Patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later
- •Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception *
- •Monocle Patients
- •Patients with epiretinal membrane as per OCT test at enrolment visit (V1)
- •Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices, abstinence or vasectomized partner. Contraception should be maintained until treatment discontinuation.
研究组 & 干预措施
NETILDEX™ ophthalmic gel
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
干预措施: NETILDEX™ ophthalmic gel (Drug)
NETILDEX™ eye drops solution
1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery.
干预措施: NETILDEX™ eye drops solution (Drug)
结局指标
主要结局
Measurement of inflammation conditions in the anterior ocular chamber after cataract extraction through Slit Lamp and Bio-microscopy.
时间窗: Throughout study completion, approximately 9 weeks.
The measurement aims to demonstrate the efficacy of a reduced frequency of administration of NETILDEX™ ophthalmic gel, administered twice daily (b.i.d.), in comparison with NETILDEX™ eye drops solution, administered four times a day (q.i.d.), in the prevention of post-surgery inflammation after cataract extraction by means of phaco-emulsification.
次要结局
- Evaluation of visual acuity through standard measurement systems.(Throughout study completion, approximately 9 weeks.)
- Evaluation of antibiotic efficacy based on the presence of detected microbial infections (positive ocular swabs and anti-biogram results, if any).(Within 24 hours after cataract surgery.)
- Evaluation of the global tolerability of NETILDEX™ ophthalmic gel in treated Patients (by the Investigator), through a standard questionnaire.(Within 2 weeks after cataract surgery.)
- Evaluation of the safety of NETILDEX™ ophthalmic gel through the collection and evaluation of adverse events.(Throughout study completion, approximately 9 weeks.)
- Assessment of a potential variation in the intra-ocular pressure related to the use of the gel formulation compared to the eye-drops formulation, through its measurement before and after treatment.(Throughout study completion, approximately 9 weeks.)
- Evaluation of clinical signs and symptoms of ocular inflammation (other than flare and cellularity) through standard scoring systems.(Throughout study completion, approximately 9 weeks.)