JPRN-jRCT2031220053招募中1 期
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
Yamazaki Hayato0 个研究点目标入组 84 人开始时间: 2022年5月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk.
- •- Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.
排除标准
- •- Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine).
- •- Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit.
- •- History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515 Travoprost XR).
- •- History of laser trabeculoplasty within 6 months prior to screening in the study eye.
- •- History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye.
- •- History or evidence of complicated cataract/lens surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc.).
- •- Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration.
- •- Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK] );or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye.
- •- History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus).
- •- Anticipated need for any incisional or laser ocular surgery in either eye during the study.
- •- History of anatomically narrow angle resulting in evidence of angle changes or any history or closed angle glaucoma in the study eye.
- •- History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye.
- •- Any history of trabeculectomy or other types of incisional glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye.
- •- Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within:
- •-- 3 years: intraocular fluocinolone acetonide
- •-- 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid
- •-- 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids
- •-- 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa.
- •- Anticipated use of other topical ocular medications in either eye except for permitted interventions.
- •- The anticipated wearing of contact lenses in the study eye(Cohort 1) and both eyes (Cohort 2) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an administration day according to the following):
- •-- Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline
- •-- Use of soft lenses should be discontinued at least 3 days
- •and use of rigid gas permeable or hard con
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