EUCTR2009-011913-26-SE进行中（未招募）不适用
A Randomized, Multicenter, Double-Masked, Parallel-Group Dose Ranging Clinical Safety and Efficacy Evaluation of BOL-303242-X Ophthalmic Suspension versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Dr. Gerhard Mann chem.-pharm Fabrik GmbH0 个研究点目标入组 550 人开始时间: 2010年1月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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 must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
- •2. Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
- •3. Subjects who are candidates for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery) in the study eye.
- •4. Subjects who, in the Investigator’s opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 or pinholed Decimal VA of 0.1 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 must be able and willing to comply with all treatment and follow-up procedures.
- •Inclusion criteria at Visit 3 (Postoperative Day 1):
- •7. Subjects who have undergone routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye.
- •8. Subjects who have =Grade 2 anterior chamber (AC) cells in the study eye
- •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 nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants throughout the duration of the study or have used any of the above within 2 days prior to surgery in either eye.
- •2.Subjects who are expected to require treatment with systemic NSAIDs throughout the duration of the study with the exception of =81 mg/day of acetylsalicylic acid.
- •3.Subjects who are expected to require treatment with any systemic (eg, oral, parenteral, inhaled, dermal, etc) or ocular (either eye) corticosteroids or glucocorticoids throughout the duration of the study or have used any systemic or ocular corticosteroids within 3 months prior to screening in either eye.
- •4.Subjects who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis) throughout the duration of the study or have used ocular immunosuppressants within 30 days prior to surgery in either eye.
- •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 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 IOP (=21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye at screening.
- •9.Subjects who are monocular or have pinholed Snellen VA 20/200 or pinholed Decimal VA of 0.1 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 for at least 2 years
- •Surgically sterile
- •Using one of the following birth control methods throughout the duration of the study:
- •?Intrauterine device (>14 days)
- •?Barrier method (condom or diaphragm) with spermicide (>14 days)
- •?Hormonal contraception (same dose and same formulation for at least 6 months)
- •12.Women who are pregnant or breastfeeding.
- •13.Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study.
- •14.Subjects who were previously randomized in this study.
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