EUCTR2010-019246-11-GB进行中（未招募）不适用
A Randomized, Multicenter, Double-Blind, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Gel, 0.5% versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subjects who are at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- •2.Subjects, who have the ability to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and, for the USA, provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •3.Subjects who are candidates for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery).
- •4.Subjects who, in the Investigator’s opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
- •5.Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
- •6.Subjects who are able and willing to comply with all treatment and follow-up/study procedures.
- •7.Subjects who have undergone routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber IOL implantation, not combined with any other surgery).
- •8.Subjects who have =Grade 2 anterior chamber cells.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who are expected to require concurrent ocular therapy (either eye) with non-steroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants during the 18 days following cataract surgery or have used any of the above within 2 days prior to surgery.
- •2.Subjects who are expected to require treatment with systemic NSAIDs during the 18 days following cataract surgery with the exception of =81 mg/day of acetylsalicylic acid.
- •3.Subjects who are expected to require treatment with systemic or ocular (either eye) corticosteroids (other than study drug) during the 18 days following cataract surgery or have used any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
- •4.Subjects who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis) during the 18 days following cataract surgery or have used ocular immunosuppressants within 30 days prior to surgery.
- •5.Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- •6.Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- •7.Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator’s opinion, may preclude study treatment or follow-up.
- •8.Subjects with elevated intraocular pressure (=21 mm Hg), uncontrolled glaucoma, or subjects being treated for glaucoma in the study eye.
- •9.Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
- •10.Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit.
- •11.Subjects who are sexually active and who do not fall into one of the following categories:
- •postmenopausal
- •surgically sterile
- •using one of the following birth control methods throughout the duration of the study:
- •?intrauterine device (>14 days of Screening Visit)
- •?barrier method (condom or diaphragm) with spermicide (>14 days of Screening Visit)
- •?hormonal contraception (same dose and same formulation for at least 6 months of Screening Visit)
- •12.Women who are breastfeeding.
- •13.Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- •14.Subjects who were previously randomized in this study.
研究者
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