PER-030-15招募中未知
THE EFFICACY AND SAFETY OF BIMATOPROST SR IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSIO
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 7
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
- 18 至 99（—）
入选标准
- •1. Male or female, ≥ 18 years.
- •2. Informed consent.
- •3. Written documentation has been obtained in accordance with the relevant country and local privacy requirements.
- •4. Patient is willing to withhold his/her IOP-lowering treatments.
- •5. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.
- •6. A negative pregnancy test result.
- •7. Diagnosis of either OAG or OHT.
- •8. Either eye can be treated adequately with timolol.
- •9. The iridocorneal angle inferiorly must be open based on clinical gonioscopic examination.
- •10. Iridocorneal angle in the study eye must be confirmed as being qualified by AS-OCT assessment.
- •11. Patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs.
- •12. Baseline visit: patient has been appropriately washed out of all IOP-lowering Medications
- •13. Baseline visit:
- •a. Hour 0 IOP in both eyes of ≥ 22 mm Hg and ≤ 32 mm Hg, with difference between eyes of ≤ 5 mm Hg
- •b. Hour 2 IOP in both eyes of ≥ 19 mm Hg and ≤ 32 mm Hg
- •14. Central Corneal Endothelial Cell Density by specular microscopy:
- •a. Screening, a minimum density of 2000 cells/mm2 in at least one eye by automated analysis
- •b. Baseline: final central density in both eyes must be confirmed.
- •15. Screening and Baseline visit: BCVA of 20/40 or better in the study eye and 20/80 or better in the fellow eye.
排除标准
- •Non-ocular Criteria
- •1. Uncontrolled systemic disease
- •2. Female patients who are pregnant or nursing.
- •3. Known allergy or sensitivity to the study medication or its components
- •4. Contraindications to beta-blocker therapy
- •8. Anticipated use of oral, intramuscular, or intravenous (IV) corticosteroids.
- •11. Known history of bleeding disorder or prolonged bleeding after surgery
- •Ocular Criteria
- •12. Patient is nonresponsive to topical ophthalmic beta-blockers
- •13. History of a traumatic cataract and/or angle recession in either eye
- •14. History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL).
- •15. Intraocular surgery and/or any ocular laser surgery
- •16. Any history of corneal graft, including partial grafts.
- •17. Incisional refractive surgery.
- •18. Corneal or other ocular abnormalities.
- •19. Any history of iris color changes associated with use of topical prostaglandins or prostamides in either eye
- •20. Active or recurrent ocular disease in either eye.
- •21. History of ocular neoplasia or herpetic ocular diseases.
- •23. History of moderate or worse (≥ +2) bulbar conjunctival hyperemia due to prostaglandin, prostamide, or prostaglandin analog use in either eye
- •24. The following anticipated wearing of contact lenses during the study.
- •25. Central corneal thickness of < 480 micrometers or > 620 micrometers in the study eye
- •26. Anticipated need for any incisional or laser ocular surgery in either eye
- •Para mayor informacion dirigirse al protocolo.
研究者
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