A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of Two Concentrations of SBI-100 Ophthalmic Emulsion in Patients With Elevated Intraocular Pressure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)
研究概览
简要总结
The goal of this clinical trial is to test in patients with glaucoma and elevated pressure in the eye. The main questions it aims to answer are: • ability to lower pressure in the eye • safety in the eye and the body of patients with elevated pressure in the eye. Patients will be randomly given either:
- 0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion
- 1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion
- Placebo Ophthalmic Emulsion
Patients will be tested before starting and will have one drop of the product placed into each eye twice a day for 14 days, by the site and by the patient. At the end of the study, researchers will compare the groups to see if there is a change from before use of SBI-100 Ophthalmic Emulsion to the end of study.
详细描述
This is a multi-center, randomized, double-masked, placebo-controlled Phase 2 study to evaluate the ocular hypotensive efficacy, safety, and tolerability of SBI-100 Ophthalmic Emulsion after 14 days of binocular dosing, twice daily (BID).
There will be a 35-day screening period, including wash-out (if needed), followed by a visit on Day-1 to confirm eligibility. The first dose will be administered by the staff immediately after the (eligibility) 08:00 IOP measurement on Day 1, with subsequent study assessments up to 8 hours post-dose. The PM (evening) dose will be self-administered by the patient at home, approximately 12 hours after the AM (morning) dose. The patient will self-administer study treatment on Days 2 through 6 in the AM and PM. On Day 7, the patient will return to have the AM dose administered by site staff immediately after the 08:00 IOP measurement has been taken. Subsequent assessments will be performed in a similar fashion as Day 1 with study assessments up to 8 hours post-dose. Patient will self-administer the Day 7 PM dose and the AM and PM doses on Days 8 through 13. On Day 14, the patient will return to have the AM dose administered by site and assessments similar to that of Days 1 and 7, the patient may complete the final dose on Day 14 at the site approximately 12 hours after the AM dose and have end of study (EOS) procedures performed. Or the patient may choose to self-administer the Day 14 PM dose at home and return to the site within 2 days for EOS visit.IOP efficacy will be evaluated by Goldmann applanation tonometry. Safety/tolerability will be evaluated by review of ocular signs and symptoms through Best Corrected Visual Acuity (BCVA), ophthalmic assessments, ocular comfort patient-reported outcome (PRO), vital signs, and other standard safety measures
Diagnosis and main criteria for inclusion: Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
Screening: up to 35 days, including wash-out from any topical pharmacological IOP-lowering therapies (if required) Treatment: 2 weeks (14 days) Follow up: Up to 2 days after the last dose on Day 14
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 (Participant, Investigator)
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
- •At least 18 years of age or greater at time of informed consent.
- •Diagnosis of either primary open angle glaucoma (POAG) or ocular hypertension (OHT) in each eye.
- •Intraocular Pressure (IOP) Criteria:
- •If currently on an IOP-lowering therapy, patient is willing to withhold therapy according to study requirements, and in the opinion of the Investigator, can do so without significant risk.
- •If treatment naïve, Screening IOP is ≥ 21 and ≤ 36 mmHg in each eye, and in the opinion of the Investigator, is likely to be controlled on a single IOP-lowering therapy.
- •08:00 Hour IOP is between 21 and 36 mmHg in each eye on Day-1 and Day
- •Central corneal thickness between 480 and 620 μm at Screening in each eye.
- •Best correct visual acuity (BCVA) for distance equivalent to 20/100 or better in each eye at Screening and Day 1 (pre-dose).
排除标准
- •Either eye:
- •Mean/Median intraocular pressure > 36 mmHg at Screening and/or any time prior to treatment administration.
- •Concurrent treatment for glaucoma requiring more than 2 topical therapies (either as 2 independent monotherapies or as fixed dose combination), oral IOP-lowering therapy and/or in the opinion of the Investigator cannot be controlled on a single IOP therapy.
- •Has planned ocular surgeries/procedures within the duration of the study.
- •Any occurrences of the following prior to Day 1:
- •Ocular trauma or surgery within 6 months
- •Ocular laser treatments within 3 months
- •In the opinion of the Investigator history or evidence of clinically significant ocular inflammation, including but not limited to blepharitis, conjunctivitis, etc.
- •History of recurrent ocular herpes (simplex or zoster)
- •Previous glaucoma intraocular surgery or glaucoma laser procedure and/or refractive surgery (e.g., radial keratotomy, PRK, SLT, LASIK, etc.) within 6 months
- •Ocular medication within 30 days prior, except for:
- •i. IOP-lowering therapies (washed-out per study requirements) ii. Lid scrubs iii. Artificial tears, gels and/or ointments to treat dry eye disease that in the opinion of the Investigator is not considered chronic use
- •Visual field loss, in the opinion of the Investigator, is functionally significant
- •Will require contact lenses and cannot refrain from using them at least 7 days prior to Day 1 and throughout the study.
- •General/Systemic:
- •Participation in any investigational study within 30 days of screening.
- •Known hypersensitivity or allergic reaction to cannabinoids, cannabis, sesame seed/oil or any component of the SBI-100 Ophthalmic Emulsion formulation and/or topical anesthetics.
- •Females of childbearing potential (not confirmed as post-menopausal or surgically sterile within the 6 months prior to screening) who are pregnant, nursing, or planning a pregnancy during the study and not using a reliable method of contraception from screening until at least 30 days after the last dose.
- •Males with partners of childbearing potential and do not agree to use a reliable method of contraception during the study and at least 30 days after the last dose.
- •Patients with a history of substance or alcohol abuse, considered chronic tetrahydrocannabinol (THC) users and/or test positive for alcohol or illicit drug use at Screening or Day-1.
研究组 & 干预措施
SBI-100 Ophthalmic Emulsion, 1%
All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion
干预措施: SBI-100 Ophthalmic Emulsion, 1.0% (Drug)
SBI-100 Ophthalmic Emulsion, 0.5%
All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion
干预措施: SBI-100 Ophthalmic Emulsion, 0.5% (Drug)
SBI-100 Ophthalmic Emulsion Placebo
All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion
干预措施: SBI-100 Ophthalmic Emulsion, Placebo (Drug)
结局指标
主要结局
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)
时间窗: baseline and day 14
To evaluate the diurnal ocular hypotensive efficacy of 2 dose levels of SBI-100 Ophthalmic Emulsion compared to placebo in patients with elevated Intraocular Pressure (IOP). IOP was measured by Goldmann applanation tonometry and values were compared between baseline and Day 14 (evaluation of mean change in mmHg (millimeters of mercury)).
Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs)
时间窗: baseline up to day 16
To evaluate the ocular and systemic safety of SBI-100 Ophthalmic Emulsion in patients with elevated IOP. Safety and tolerability were evaluated by review of ocular signs and symptoms through use of BCVA (best corrected visual acuity; change in score from baseline to Day 14), ophthalmic assessments) including slit lamp biomicroscopy, dilated fundus exam, pupil diameter, visual field and pachymetry), ocular comfort patient reported outcome, vital signs, assessment of adverse events (ocular and non-ocular).
次要结局
未报告次要终点