CTRI/2025/07/090630招募中4 期
A Multicenter, Open Label, Single-Arm, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 percentage w/v for the treatment in Participants with Presbyopia.
Entod Pharmaceuticals Ltd.9 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 9
- 主要终点
- 1.The assessment of the safety of participants [Based on the incidence of treatment emergent adverse event(TEAE)].
研究概览
简要总结
A Multicenter, Open Label, Single-Arm, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 % w/v for the treatment in Participants with Presbyopia.
Study Objective:
Primary objective: To evaluate the safety and tolerability of Pilocarpine Hydrochloride ophthalmic solution for the treatment in participants with presbyopia.
Secondary objectives: To evaluate the efficacy of Pilocarpine Hydrochloride ophthalmic solution for the treatment in participants with presbyopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female participants, 45 to 55 years of age (both inclusive).
- •Participants with subjective complaints of poor near vision that impacts the activity of daily living.
- •Participants with photopic, high-contrast Corrected Distance Visual Acuity (CDVA) of 20/25 or better bilaterally; mesopic, high-contrast Distance-Corrected Near Visual Acuity (DCNVA, measured at 40cm) of 20/40 to 20/100; photopic, near visual acuity correctable to 20/40 or better bilaterally.
- •Participants with willingness to wear monofocal correction to achieve photopic, binocular CDVA of 20/32 or better during the study.
- •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation or cholinergic agonist medications.
- •Participants with history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any other intraocular surgery.
- •Participants with concurrent use of any topical ophthalmic medications including artificial tears, other than the study intervention during the course of the study.
- •Participants with concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
- •Participants with severe dry eye disease.
- •Participants with pathological myopia.
- •Participants with corneal abnormalities (including Keratoconus,corneal scar, Fuchs endothelial dystrophy, guttata or edema) in either eye that are likely to interfere the visual acuity.
- •Participants with history of iris trauma, Adies’ tonic pupil, abnormal pupil shape in either eye, or anisocoria greater than 1mm between pupils under mesopic conditions at the screening visit.
- •Participants with diagnosis of Glaucoma or ocular Hypertension.
- •Narrow iridocorneal angles (Shaffer grade less than or equal to 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy.
- •Participants with Bifocal or multifocal spectacles or contact lenses for habitual correction.
- •Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.
- •Participants with history of chronic, recurrent, or current severe inflammatory eye disease (i.e.scleritis, uveitis, herpes keratitis) in either eye.
- •Participants with documented history of ocular trauma 6 months before the study.
- •Participants with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, retinal hole or tear, diabetic retinopathy, retinal detachment, peripheral retina is showing lattice degeneration) in either eye.
- •Participants with use of topical ophthalmic corticosteroid within two weeks prior to baseline visit.
- •Participants with use of intraocular corticosteroid implant at any time prior to baseline visit.
- •Presence of a severe or serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow up.
- •Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic and renal diseases.
- •Participants currently participating in any other clinical trial or has participated in any other clinical trial 30 days prior to screening.
- •Suspected inability or unwillingness to comply with the protocol or other study procedures.
- •Female participants who are pregnant or lactating or planning to become pregnant during the study period.
- •Females or males who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
1.The assessment of the safety of participants [Based on the incidence of treatment emergent adverse event(TEAE)].
时间窗: 150 Days
2.The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.
时间窗: 150 Days
次要结局
- 1. Percentage of participants Gaining 3 Lines or More in Mesopic (10-11 lux at the target), High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) on Day 120, hours 3, 6 and 9 [Time Frame: Baseline Day 1 to Day 120 (Hours 3, 6 and 9)].(120 Days)
- 2. Proportion of participants Achieving 20/40 or Better in Photopic (Greater than 251 lux at the target), High-contrast, Binocular, DCNVA on Day 120, hour3[ Time Frame: Day 120 (Hour 3)].(120 Days)
- 3. Mean change from baseline in photopic, high-contrast, binocular Distance-Corrected Intermediate Visual Acuity (DCIVA; measured at 66 cm) letters on Day 120, hour 3 [Time Frame: Day 1 to Day 120 (Hour 3)].(120 Days)
- 4. Mean Change from Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score on Day 120, Hour 3.(120 Days)
- 5. Mean Change from Baseline in Pelli-Robson contrast measurement score on Day 120.(120 Days)
研究者
Dr Rohit Saxena
Dr Rajendra Prasad Centre for Ophthalmic Science
研究点 (9)
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