EUCTR2010-022178-14-PL进行中（未招募）不适用
A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X (0.006%, 0.012%, 0.024% and 0.040%) to Latanoprost 0.005% in Subjects with Open Angle Glaucoma or Ocular Hypertension
Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH/Bausch & Lomb0 个研究点目标入组 400 人开始时间: 2010年11月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 must be of legal age (at least 18) on the date the Informed Consent Form
- •(ICF) is signed and with the capacity to provide voluntary informed consent.
- •2. Subjects must be able to read, understand, and provide written informed consent on
- •the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and
- •provide authorization as appropriate for local privacy regulations.
- •3. Subjects must have a diagnosis of open angle glaucoma (OAG) (including
- •pigmentary or pseudoexfoliative) or ocular hypertension (OH) in one or both eyes.
- •4. Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 1
- •[after washout for the subjects already on treatment]):
- •- a mean/median IOP = 26 mm Hg at a minimum of one time point, = 24 mm Hg at
- •a minimum of one time point, and = 22 mm Hg at one time point in the same eye
- •- mean/median IOP = 32 mm Hg in both eyes at all three measurement time points
- •5. Subjects with best-corrected visual acuity (BCVA), using Early Treatment of
- •Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen
- •equivalent ~20/100) or better in either eye.
- •6. Women of childbearing potential who have a negative urine pregnancy test result at
- •Visit 1 (Screening), Visit 3 (Eligibility, Day 1), and Visit 6.
- •7. Female subjects of childbearing potential are eligible for the study but should be
- •willing to use adequate (at least one form of) contraceptive methods as described
- •below during the treatment period (approximately 28 days). Male subjects with
- •partners of childbearing potential must agree to use adequate (at least one form of)
- •contraception as described below during the treatment period (approximately 28
- •- Acceptable contraceptive methods for female (need at least one):
- •? hormonal methods of contraception (including oral and transdermal
- •contraceptives, injectable progesterone, progestin subdermal implants,
- •progesterone-releasing intrauterine devices [IUDs]) initiated at least 14 days
- •prior to the first dose of trial medication
- •? abstinence
- •? placement of a copper-containing IUD
- •? condom with spermicidal foam/gel/film/cream/suppository
- •? postmenopausal at least 12 months or permanently sterilized (eg, tubal
- •occlusion, hysterectomy, bilateral salpingectomy)
- •? male partner who has had a vasectomy for at least 3 months
- •- Acceptable contraceptive methods for male subjects with partners of childbearing
- •potential (need at least one):
- •? abstinence
- •? vasectomy for at least 3 months
- •? without a vasectomy, must use a condom
- •8. Subjects who are able and willing to comply with all treatment and follow-up/study
- •procedures.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. Subjects participating in any drug or device clinical investigation within 30 days prior to the Visit 1 (Screening) and/or during the period of study participation.
- •2. Women who are breastfeeding.
- •3. Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- •4. Subjects with known contraindications to nitric oxide (NO) treatment (ie, history of severe hypotension, alcohol abuse, or hypersensitivity to any of the drug components).
- •5. Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study medication and during study visits.
- •6. Subjects whose central corneal thickness is greater than 590 µm in either eye.
- •7. Subjects with any condition that prevented reliable applanation tonometry (eg, significant corneal surface abnormalities) in either eye.
- •8. Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
- •9. Subjects with previous or active corneal disease.
- •10. Subjects with history of severe dry eye.
- •11. Subjects with monophthalmia.
- •12. Subjects with optic disc hemorrhage.
- •13. Subjects with a history of central retinal vein and artery occlusion.
- •14. Subjects with a history of macular edema.
- •15. Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
- •16. Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
- •17. Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer’s anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
- •18. Subjects with a diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
- •19. Subjects who are expected to require treatment with ocular or systemic corticosteroids.
- •20. Subjects who are in need of any other topical or systemic treatment of OAG or OH.
- •21. Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP (eg, ß-adrenergic antagonists, a-adrenergic agonists, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II receptor blockers) during the study period.
- •22. Subjects with severe dysfunction of the liver or the kidneys.
- •23. Subjects with active wasting disease including cancer.
- •24. Subjects with angina pectoris not controlled by medical or surgical treatment.
- •25. Subjects with severe asthma bronchiale (FEV < 70% of predicted value).
- •26. Subjects with hematological diseases such as aplastic anaemia, pancytopenia, or hemolytic icterus.
- •27. Subjects whose concomitant use of medications may interact with the safety or efficacy of a NO donating compound (eg, calcium channel blockers such as Cardiazem and vasodilators such as Isordil and BiDil).
- •28. Subjects who are unwilling to discontinue the use of phosphodiesterase inhibitors such as Viagra, Revatio, Levitra, or Cialis during the study.
- •29. Subjects with 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.
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