Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug in Patients With Open Angle Early Visual Field Defects Glaucoma or Ocular Hypertension in Comparison to Xalatan © Eye Drops in the Second Eye
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety Endpoint - the incidence of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
研究概览
简要总结
Glaucoma is the most frequent cause of irreversible & preventable blindness worldwide, affecting about 2% of the world's population in people over 40. The major risk factor, and only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can slow or arrest the progression of vision loss.
Current treatment consists of drops administered on a daily basis with unfortunately low patient compliance, increasing the chance of blindness.
Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus solves the significant problem of patient compliance.
详细描述
Device Description - A combination of punctual plug (new product) as delivery system for Latanoprost (already approved drug). The plug has 2 different sizes of "big plug" (450 µg API) and "small plug" (250 µg API) (Neck diameter of 1.08 mm and 1.06 mm, accordingly) EXP-LP punctum plug is intended to be used as drug delivery system to improve patient compliance and outcomes. EXP-LP is a combination therapy non-invasive insert that replaces eye drops and provides sustained drug therapy for chronic eye problems such as glaucoma.
Xalatan (latanoprost) has been marketed for nearly 15 years, and its performance in reducing IOP is well established Study Design - This is a prospective, single center, open-label, controlled ("split body" design) non-randomized study performed in early visual field defects open angle glaucoma or ocular hypertension patients.
Study Population and Justification - 40 patients with open angle early visual field defects glaucoma (treated with eye drop medications) or ocular hypertension will be enrolled to the study. Due to early feasibility stage of the study, no formal sample size calculation was done for this study.
The intent to treat (ITT) population, defined as enrolled participants including those who leave the study prematurely during the screening period (before EXP-LP insertion).
Handling of Participant Withdrawals - Participants who leave the study prematurely during the screening period (before EXP-LP insertion) will not be replaced and will not be accounted for in the ITT study population. The discontinuing patient will be followed for safety by a phone call, one month after exiting the study. Each case of premature withdrawal will be properly recorded in the Screening Failure Log.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18-80 years consecutive males or females diagnosed with open angle early visual field defects glaucoma or ocular hypertension in both eyes and treated with eye drop medications .
- •Treated IOP lower than 26 mmHg on at least 2 consecutive examinations.
- •If glaucoma, mean deviation must be better than -10 mmHg in study eye (early visual field defects glaucoma)
- •IOP increase of at least 3 mmHg from start of washout in both eyes.
排除标准
- •Any record of IOP ever being higher than 33 mmHg.
- •Corneal or other anatomical abnormalities preventing reliable applanation tonometry
- •Severe dry eye,
- •Use of contact lenses
- •Intolerance or contraindication to latanoprost or BAK
- •Indication of optic nerve damage and visual function deterioration according to the investigator's judgment
- •Lower lacrimal Punctum (tear duct) diameter is smaller than 0.4mm or greater than or equal to 0.75mm
- •Pregnancy or lactation (questioned by the consenting investigator), unwillingness to avoid pregnancy
- •Use of (topical or systemic) corticosteroids within 2 months before enrolment. Any systemic condition or medication that can affect IOP.
- •Known intolerance to PGA eye drops
- •Use of oral IOP-lowering medication
- •Punctual occlusions or other anatomic abnormality
- •Previous incisional ocular surgery (e.g., conventional filtering surgery) to lower IOP
- •Evidence of current or prior angle closure
研究组 & 干预措施
EXP-LP punctum plug
EXP-LP is a novel and innovative drug delivery system aiming to improve patient compliance and outcomes. EXP-LP punctum plug, is a non-invasive insert that replaces eye drops and provides sustained therapy for glaucoma, dry eye and other major eye diseases. EXP-LP is a combination of an ophthalmic prostaglandin drug (Latanoprost). The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye
干预措施: drug delivery system (Device)
XALATAN®
XALATAN® (latanoprost ophthalmic solution) is an eye drop used to treat high eye pressure/intraocular pressure in people with open-angle glaucoma or ocular hypertension. XALATAN is administrated once a day
干预措施: XALATAN® (Drug)
结局指标
主要结局
Safety Endpoint - the incidence of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
时间窗: Will be evaluated through study completion (3 months)
Main Adverse Event that will be focused on during the study: * Irritation and local discomfort * Increased Lacrimation * Increased mucus * Intraocular inflammation * Ocular redness * Eyelid Edema * Hyperaemia conjunctival erythema * Keratitis
次要结局
- Tolerability Endpoint - The incidence of subjects withdrew due to plug inconvenience and plug incompatibility(Will be evaluated through study completion (3 months))