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Abstract：
UNASSIGNED: The purpose of this study was to evaluate the safety and tolerability profile of drugs used for treating common eye disorders when applied to normal healthy volunteers (NHVs) as explored in phase 1 trials.
UNASSIGNED: A total of 166 NHVs were identified in six phase 1 trials, examined in a retrospective analysis. The primary endpoints were visual comfort (by ocular comfort index, OCI) and safety (laboratory evaluations, vital signs (VS), visual acuity (VA), intraocular pressure (IOP), lissamine green and fluorescein staining, conjunctival hyperemia, chemosis, and adverse events\' incidence (AE)).
UNASSIGNED: Compared to baseline, 75.9%, 40.4% and 73.7% of NHV (for lubricant, hypotensive and antibiotic treatments, respectively) improved their OCI score by their final visit. Laboratory evaluations and VS were within normal ranges in 88% of NHV. Similar results were found for VA, corneal and conjunctival staining, and chemosis. IOP decreased significantly in the hypotensive agents\' group, trace to mild hyperemia was reported in 32.1%, 27.1%, and 6.8%, respectively. Additionally, lubricant and hypotensive investigational drugs (ID) had a lower risk of incidence of AE than approved drugs (OR 0.856, 95% CI [0.365, 1.999] and 0.636, 95% CI [0.096, 4.197], respectively). Meanwhile, on antibiotic drugs, the risk for ID-related AE was higher (OR 1.313, 95% CI [0.309, 5.583]).
UNASSIGNED: Phase 1 trials are important in order to ensure the safety and tolerability of ophthalmic medications. This study demonstrates that NHVs do not face a significant risk of harm in these studies, since 98% of the reported AE were mild, and all AE were resolved by the end of the study in which they appeared.
UNASSIGNED: This is a retrospective study of six previously conducted clinical trials, registered on clinicaltrials.gov with the following registration IDs: NCT04081610, NCT03524157, NCT03520348, NCT03966365, NCT03965052 and, NCT03519516.
UNASSIGNED: A total of 166 NHVs were identified in six phase 1 trials, examined in a retrospective analysis. The primary endpoints were visual comfort (by ocular comfort index, OCI) and safety (laboratory evaluations, vital signs (VS), visual acuity (VA), intraocular pressure (IOP), lissamine green and fluorescein staining, conjunctival hyperemia, chemosis, and adverse events\' incidence (AE)).
UNASSIGNED: Compared to baseline, 75.9%, 40.4% and 73.7% of NHV (for lubricant, hypotensive and antibiotic treatments, respectively) improved their OCI score by their final visit. Laboratory evaluations and VS were within normal ranges in 88% of NHV. Similar results were found for VA, corneal and conjunctival staining, and chemosis. IOP decreased significantly in the hypotensive agents\' group, trace to mild hyperemia was reported in 32.1%, 27.1%, and 6.8%, respectively. Additionally, lubricant and hypotensive investigational drugs (ID) had a lower risk of incidence of AE than approved drugs (OR 0.856, 95% CI [0.365, 1.999] and 0.636, 95% CI [0.096, 4.197], respectively). Meanwhile, on antibiotic drugs, the risk for ID-related AE was higher (OR 1.313, 95% CI [0.309, 5.583]).
UNASSIGNED: Phase 1 trials are important in order to ensure the safety and tolerability of ophthalmic medications. This study demonstrates that NHVs do not face a significant risk of harm in these studies, since 98% of the reported AE were mild, and all AE were resolved by the end of the study in which they appeared.
UNASSIGNED: This is a retrospective study of six previously conducted clinical trials, registered on clinicaltrials.gov with the following registration IDs: NCT04081610, NCT03524157, NCT03520348, NCT03966365, NCT03965052 and, NCT03519516.
摘要：
■本研究的目的是评估1期试验中用于正常健康志愿者（NHV）治疗常见眼部疾病的药物的安全性和耐受性。
■在六项1期试验中总共确定了166只NHV，在回顾性分析中进行了检查。主要终点是视觉舒适度(通过眼部舒适度指数，OCI)和安全性(实验室评估，生命体征（VS），视敏度（VA），眼内压（IOP），Lissamine绿色和荧光素染色，结膜充血，化疗，和不良事件发生率（AE））。
■与基线相比，75.9%,40.4%和73.7%的NHV(对于润滑剂，降血压和抗生素治疗，分别)在最后一次访问时提高了他们的OCI得分。88%NHV的实验室评估和VS在正常范围内。对于VA也发现了类似的结果，角膜和结膜染色，和化学.降压药组的眼压显著下降，据报道有32.1%的人出现轻度充血，27.1%,和6.8%，分别。此外,润滑剂和低血压研究药物(ID)的AE发生率低于批准药物(OR0.856,95%CI[0.365,1.999]和0.636,95%CI[0.096,4.197],分别)。同时,抗生素药物，ID相关AE的风险较高(OR1.313,95%CI[0.309,5.583]).
■为了确保眼科药物的安全性和耐受性，第一阶段试验很重要。这项研究表明，NHV在这些研究中不会面临重大的伤害风险，由于98％的报告AE是轻度的，所有AE在研究结束时都得到解决。
■这是一项先前进行的六项临床试验的回顾性研究，在clinicaltrials.gov上注册，注册ID如下：NCT04081610、NCT03524157、NCT03520348、NCT03966365、NCT03965052和，NCT03519516。
■在六项1期试验中总共确定了166只NHV，在回顾性分析中进行了检查。主要终点是视觉舒适度(通过眼部舒适度指数，OCI)和安全性(实验室评估，生命体征（VS），视敏度（VA），眼内压（IOP），Lissamine绿色和荧光素染色，结膜充血，化疗，和不良事件发生率（AE））。
■与基线相比，75.9%,40.4%和73.7%的NHV(对于润滑剂，降血压和抗生素治疗，分别)在最后一次访问时提高了他们的OCI得分。88%NHV的实验室评估和VS在正常范围内。对于VA也发现了类似的结果，角膜和结膜染色，和化学.降压药组的眼压显著下降，据报道有32.1%的人出现轻度充血，27.1%,和6.8%，分别。此外,润滑剂和低血压研究药物(ID)的AE发生率低于批准药物(OR0.856,95%CI[0.365,1.999]和0.636,95%CI[0.096,4.197],分别)。同时,抗生素药物，ID相关AE的风险较高(OR1.313,95%CI[0.309,5.583]).
■为了确保眼科药物的安全性和耐受性，第一阶段试验很重要。这项研究表明，NHV在这些研究中不会面临重大的伤害风险，由于98％的报告AE是轻度的，所有AE在研究结束时都得到解决。
■这是一项先前进行的六项临床试验的回顾性研究，在clinicaltrials.gov上注册，注册ID如下：NCT04081610、NCT03524157、NCT03520348、NCT03966365、NCT03965052和，NCT03519516。
