A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma
概览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- intraocular pressure (IOP)
概览
简要总结
Objectives: To evaluate the non-inferiority in the intraocular pressure decrease of the preservative-free ophthalmic solution PRO-122, manufactured by Laboratorios Sophia S.A. de C.V., versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma and/or IOP.
Hypothesis: The mean (average) value of the IOP final absolute reduction in the experimental group (PRO-122) is not lower, considering a lower limit of 1 mmHg, compared to the IOP mean absolute reduction of the standard group (concomitant therapy).
Methodology: A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial
详细描述
Number of patients: 51 subjects divided into 3 groups (17 subjects per group)
Diagnosis and main inclusion criterion:
Diagnosis: Primary open-angle glaucoma or ocular hypertension
Main criteria:
- Patients of either sex
- Average intraocular pressure (IOP) ≤ 36 mm/Hg
- Previous management with ocular hypotensive medications ≥ 2 months, without achieving control (target IOP)
- Age ≥ 18 years
- Informed consent
Test product, dosage and route of administration:
- PRO-122. Preservative-free ophthalmic solution of timolol 0.5% / brimonidine 0.2% / dorzolamide 2% Manufactured by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. + Placebo + Placebo
- Dosage: 1 drop every 12 hours
- Route of administration: ophthalmic
Treatment duration: 90 days
Evaluation criteria:
Efficiency (non-inferiority):
- IOP decrease
Safety:
-
Best corrected visual acuity
-
Cup-to-disc ratio
-
Visual fields determined by computerized perimetry
-
Central corneal thickness determined by pachymetry
-
Ocular surface integrity, including:
-
Conjunctival hyperemia
-
Chemosis
-
Fluorescein staining
-
Density of goblet cells
-
Adverse events
Tolerability:
- Ocular comfort index
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for quantitative variables. The qualitative variables will be presented in frequencies and percentages. Statistical analysis will be done by means of a Kruskal-Wallis test for quantitative variables. The difference between qualitative variables will be analyzed using an square chi An alpha ≤ 0.05 would be considered as significant.
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)
盲法说明
Blinding will be performed by the personnel assigned by the Laboratorios Sophia S.A. de C.V. Clinical Operations Management. The blinding will consist in the elimination of the primary label (commercial) for Krytantek Ofteno® and the triple concomitant therapy and the placement of a label identical to those of the other interventions. Since the bottles in which Krytantek Ofteno® and the concomitant therapies are different in color and cap shape to the ones used for the placebo and the PRO-122, a masking will be performed in the primary packaging, which shall be identical for all three interventions.
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
- •Signed informed consent
- •Age greater or equal to 18 years
- •Both sexes
- •Women of childbearing age with birth control method
- •Diagnosis of Primary open-angle glaucoma (according to the Guidelines of the Preferred Practice Pattern of the American Academy of Ophthalmology) or ocular hypertension (OHT)
- •Intraocular pressure (IOP) not controlled with dual therapy according to the principal investigator (PI) judgment.
- •IOP on the selection visit at 9 am, after the washing period, from 21 - 36 mmHg in at least one eye.
排除标准
- •General criteria
- •Pregnant, breastfeeding or planning to get pregnant women.
- •Women of childbearing age and who do not intake a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- •Participation in another clinical research study greater or equal 30 days before the screening visit.
- •People who cannot comply with their attendance at appointments or with all the - Protocol requirements
- •Medical and therapeutic criteria:
- •Anterior chamber angle grade less than 2 of Shaffer rating.
- •Excavation of optic nerve greater than 0.80 horizontal or vertical (ratio cup-disc)
- •Serious loss of central visual field in any eye (sensitivity less or equal to 10 decibels in greater or equal to 2 of 4 points of the visual field test close to the fixation point)
- •People not able to safely suspend ocular hypotensives drug products for the washout period according to the PI judgement.
研究组 & 干预措施
PRO-122 group
To validate the 3 flasks of the triple therapy will be used 1 bottle with the three active principles (PRO-122) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. preservative free.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution, preservative free
-
Package description: 5 m multidose dropper bottle.
-
Placebo (for
-
Two pieces of approved placebo. Administered in 2 multidose dropper bottles.
-
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: PRO-122 (Drug)
PRO-122 group
To validate the 3 flasks of the triple therapy will be used 1 bottle with the three active principles (PRO-122) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. preservative free.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution, preservative free
-
Package description: 5 m multidose dropper bottle.
-
Placebo (for
-
Two pieces of approved placebo. Administered in 2 multidose dropper bottles.
-
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: Placebo1 (Other)
PRO-122 group
To validate the 3 flasks of the triple therapy will be used 1 bottle with the three active principles (PRO-122) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. preservative free.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution, preservative free
-
Package description: 5 m multidose dropper bottle.
-
Placebo (for
-
Two pieces of approved placebo. Administered in 2 multidose dropper bottles.
-
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: Placebo 2 (Other)
Concomitant triple therapy group
Imot Ofteno
Drug substance: Timolol 5 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by Laboratorios Sophia S.A. de C.V.
Alphagan
Drug substance Brimonidine 2 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Allergan, Inc.
Trusopt
Drug substance: Dorzolamide 20 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Merck Sharp and Dohme Corp.
Posology: 1 drop every 12 hours for 90 days
干预措施: Timolol eye drops (Drug)
Concomitant triple therapy group
Imot Ofteno
Drug substance: Timolol 5 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by Laboratorios Sophia S.A. de C.V.
Alphagan
Drug substance Brimonidine 2 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Allergan, Inc.
Trusopt
Drug substance: Dorzolamide 20 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Merck Sharp and Dohme Corp.
Posology: 1 drop every 12 hours for 90 days
干预措施: Dorzolamide-Timolol Ophthalmic (Drug)
Concomitant triple therapy group
Imot Ofteno
Drug substance: Timolol 5 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by Laboratorios Sophia S.A. de C.V.
Alphagan
Drug substance Brimonidine 2 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Allergan, Inc.
Trusopt
Drug substance: Dorzolamide 20 mg/mL
Pharmaceutical form: Ophthalmic solution
Made by: Merck Sharp and Dohme Corp.
Posology: 1 drop every 12 hours for 90 days
干预措施: Brimonidine Ophthalmic Solution (Drug)
Krytantek Ofteno Group
To validate the three flasks of the triple therapy will be used 1 bottle with the three active principles (Krytantek) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution Package description: 5 m multidose dropper bottle.
Placebo (for two pieces of approved placebo. Administered in 2 multidose dropper bottles.
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: Placebo1 (Other)
Krytantek Ofteno Group
To validate the three flasks of the triple therapy will be used 1 bottle with the three active principles (Krytantek) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution Package description: 5 m multidose dropper bottle.
Placebo (for two pieces of approved placebo. Administered in 2 multidose dropper bottles.
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: Placebo 2 (Other)
Krytantek Ofteno Group
To validate the three flasks of the triple therapy will be used 1 bottle with the three active principles (Krytantek) and two placebos and thus comply with the masking.
Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL.
Pharmaceutical form: Ophthalmic solution
Made by: Laboratorios Sophia, S.A. de C.V.
Posology: 1 drop every 12 hours for 90 days
Description of the solution: clear, visibly particle free, slightly yellow solution Package description: 5 m multidose dropper bottle.
Placebo (for two pieces of approved placebo. Administered in 2 multidose dropper bottles.
Posology: 1 drop of each dropper bottle every 12 hours for 90 days
干预措施: Krytantek (Drug)
结局指标
主要结局
intraocular pressure (IOP)
时间窗: 90days
Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg
次要结局
未报告次要终点