Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma
试验速览
- 阶段
- 4 期
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Post-treatment IOP
研究概览
简要总结
Glaucoma is the second leading cause of blindness and the first leading cause of irreversible vision loss worldwide. The intraocular pressure (IOP) is the only modifiable risk factor for all the spectrum of glaucoma. Reducing IOP in glaucoma increases the likelihood of preventing progression of the disease and preserving the quality of life of the patient. Although prostaglandin analogs (PGAs) and prostamides (PMs) are de facto first-line treatment options for managing glaucoma, it is a common clinical experience to see their treatment effects plateau to a level beyond which no clinically significant IOP reduction is likely. It is also common to find minimal IOP treatment effects in the following conditions: patients with normal tension glaucoma (NTG), patients with thicker central corneal thickness (CCT), and patients with higher levels of corneal hysteresis (CH). CH is a possible proxy for the ability of the scleral tissue around the optic nerve to dissipate energy away from the optic nerve fibers. Netarsudil, a rho-kinase inhibitor was recently approved by the FDA for the treatment of glaucoma and ocular hypertension. There is a paucity of research on the efficacy of netarsudil in patients with NTG, thicker CCT, and higher levels of CH. This study aims to investigate the above issues by evaluating the efficacy of netarsudil and bimatoprost in subjects with NTG, thicker corneas, and higher levels of CH.
Hypotheses
- Netarsudil will have non-inferior efficacy compared to Bimatoprost in treating NTG.
- Corneal thickness and corneal hysteresis will reduce the efficacy of netarsudil similar to bimatoprost in NTG.
- Netarsudil will change corneal thickness and corneal hysteresis similar to bimatoprost in NTG.
详细描述
CHARACTERISTICS OF THE SUBJECT POPULATION
- Target Accrual. The target number of participants we aim to recruit is one hundred and fifteen (115). Participants will be recruited from the patient base of Roberts Eyecare Associates in Vestal, New York, and from referrals from other practices.
- Gender of the Subjects. There will be no gender restriction in the study.
- Age Range of Adult Subjects. The age range of participants is 21 to 89 years. This age range is based on the Collaborative Normal Tension Glaucoma Study (CNTGS).
- Age Range of Pediatric Subjects. Not applicable.
- Racial and Ethnic Origin. There will be no restriction based on race or ethnicity.
- Vulnerable Subjects. It is not anticipated that the study will include vulnerable subjects like pregnant persons, breastfeeding persons, persons considering becoming pregnant, children, prisoners, individuals with impaired decision-making capacity, Salus employees and/or students. However, if any subject meeting the inclusion criteria is determined to be a vulnerable subject as defined above, they will be excluded for participation.
METHODS AND PROCEDURES
- Patient History
The initial examination will include a comprehensive patient history that will include the following:
- date of birth
- race/ethnicity
- ocular and general medical history
- list of the medications
- family ocular and general medical history
- allergy history
- social history, including history of smoking, alcohol, and recreational drug use.
- Procedures at first visit
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New NTG patients naïve to treatment.
- •Patient with 360 degrees open angles on gonioscopy.
- •Patients with glaucomatous optic neuropathies (GON).
- •Patients with three repeatable visual field defects over two visits.
- •Subjects must have IOPs ≤ 21 mmHg and no recorded IOPs > 21 mmHg at any time.
- •Glaucomatous optic neuropathy and visual field criteria:
- •Category 1 and 2 of the glaucoma diagnostic criteria of the International Society of Geographical and Epidemiological Ophthalmology (ISGEO) will be adopted in this study.
- •ISGEO Category 1 classification of glaucoma:
- •Reliable and repeatable visual field defects consistent with a glaucomatous optic neuropathy, and either a vertical cup-disc ratio (VCDR) at the 97.5th percentile of the normal population (about 0.7 VCDR), or VCDR asymmetry between the right and left eyes at the 97.5th percentile of the normal population (i.e., about 0.2).
- •ISGEO Category 2 classification of glaucoma:
- •Visual field results are not definitive or are unattainable due to patient inability to perform an adequate quality test, and optic disc has VCDR of at the 99.5th percentile of the normal population (i.e., VCDR of about 0.9) or VCDR asymmetry between the right and left eyes at the 99.5th percentile of the normal population (i.e a CDR asymmetry of about 0.3).
- •Exclusion Criteria
- •Patients with IOPs greater than 21 mmHg at any previous point in time
- •Patients with corneal pathology
- •Previous ocular surgery in the past 6 months
- •Patients with any other types of glaucoma other than NTG
- •Patients who are unwilling or unable to follow-up for a 3-month period
- •Patients with systemic conditions where a non-glaucomatous optic neuropathy cannot be ruled out.
- •Subjects who are pregnant, breastfeeding, or considering becoming pregnant
- •Subjects who could be pregnant will be screened for pregnancy thus: Those who are not pregnant nor considering becoming pregnant and are not on any birth-control at the time of recruitment will be excluded from participation because of the risk of pregnancy unknown to the patient at the time of recruitment.
排除标准
- 未提供
研究组 & 干预措施
Group 1: Normal tension glaucoma subjects with thin corneas
NTG subjects with CCT ≤ 540 nm will be randomized to receive either netarsudil or bimatoprost.
干预措施: Netarsudil Ophthalmic (Drug)
Group 1: Normal tension glaucoma subjects with thin corneas
NTG subjects with CCT ≤ 540 nm will be randomized to receive either netarsudil or bimatoprost.
干预措施: Bimatoprost Ophthalmic (Drug)
Group 2: Normal tension glaucoma subjects with thick corneas
NTG subjects with CCT > 540 nm will be randomized to receive either netarsudil or bimatoprost.
干预措施: Netarsudil Ophthalmic (Drug)
Group 2: Normal tension glaucoma subjects with thick corneas
NTG subjects with CCT > 540 nm will be randomized to receive either netarsudil or bimatoprost.
干预措施: Bimatoprost Ophthalmic (Drug)
结局指标
主要结局
Post-treatment IOP
时间窗: 3 months post-treatment
Change in IOPs (GAT, DCT, and ORA) from baseline.
次要结局
- Post-treatment change in CCT(3 months post-treatment)
- Post-treatment change in CH(3 months post-treatment)
- Post-treatment IOP change by CCT(3 months post-treatment)
- Post-treatment IOP change by CH(3 months post-treatment)