EUCTR2013-000553-45-GB进行中（未招募）1 期
A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing theSafety and Efficacy of BOL-303259-X 0.024% (Latanoprostene Bunod) OphthalmicSolution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects WithOpen-Angle Glaucoma or Ocular Hypertension – LUNAR Study - LUNAR study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 393
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 years) 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/Ethics
- •Committee-approved ICF and provide authorization as appropriate
- •for local privacy regulations.
- •3. Subjects who are able and willing to comply with all treatment and
- •follow-up/study procedures.
- •4. Subjects who are not of childbearing potential or female subjects
- •who have a negative urine pregnancy test result at Visit 1
- •(Screening) and Visit 3 (Eligibility, Day 0).
- •5. Female subjects of childbearing potential are eligible for the study
- •but should be willing to use adequate (at least 1 form of)
- •contraceptive methods as described below during the study treatment
- •period plus 7 days (starting from the first dose of study drug and
- •ending 7 days after the last dose of study drug).
- •Male subjects with partners of childbearing potential must agree to
- •use adequate (at least 1 form of) contraception as described below
- •during the study treatment period plus 7 days (starting from the first
- •dose of study drug and ending 7 days after the last dose of study
- •- Acceptable contraceptive methods for female subjects (need at
- •least one):
- •o 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 study drug
- •o True abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- •o Placement of a copper-containing IUD
- •o Condom with spermicidal foam/gel/film/cream/suppository
- •o Postmenopausal at least 12 months (365 days) prior to the
- •first dose of study drug or permanently sterilized (eg, tubal
- •occlusion, hysterectomy, bilateral salpingectomy)
- •o Male partner who has had a vasectomy for at least 3 months
- •(90 days) prior to the first dose of study drug or is
- •surgically sterile
- •- Acceptable contraceptive methods for male subjects with
- •partners of childbearing potential (need at least one):
- •o True abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- •o Vasectomy for at least 3 months (90 days) prior to the first
- •dose of study drug or surgically sterile
- •o Without a vasectomy, must use a condom with spermicidal
- •foam/gel/film/cream/suppository
- •Ocular Inclusion Criteria
- •6. Subjects must have a diagnosis of OAG (including pigmentary or
- •pseudoexfoliative) or OHT in 1 or both eyes.
- •7. Subjects must meet the following IOP requirements at Visit 3
- •(Eligibility, Day 0 [after washout for the subjects currently under
- •treatment with an IOP-lowering medication]):
- 另有 6 项未显示
排除标准
- •1. Subjects participating in any drug or device clinical investigation
- •within 30 days prior to Visit 1 (Screening) for subjects who require a
- •washout period or 30 days prior to Visit 3 (Eligibility, Day 0) for
- •subjects who do not require a washout period.
- •2. Subjects who are known to have been exposed to BOL-303259-X
- •(formerly identified as NCX 116 and PF 03187207) in any previous
- •clinical investigation prior to Visit 1 (Screening).
- •32. Subjects with any intraocular infection or inflammation in either eye
- •within 3 months (90 days) prior to Visit 1 (Screening).
- •33. Subjects with a history of ocular laser surgery in either eye within
- •the 3 months (90 days) prior to Visit 1 (Screening).
- •34. Subjects with a history of incisional ocular surgery or severe trauma
- •in either eye within 3 months (90 days) prior to Visit 1 (Screening).
- •3. Subjects who anticipate participating in any other drug or device
- •clinical investigation within the duration of this study.
- •4. Female subjects who are pregnant or breastfeeding.
- •5. Subjects with a history or presence of any of the following:
- •- Severe dysfunction of the liver or the kidneys
- •- Wasting disease
- •- Angina pectoris not controlled by medical or surgical treatment
- •- Severe asthma
- •- Hematological diseases such as aplastic anemia, pancytopenia,
- •or hemolytic icterus
- •- Severe chronic obstructive pulmonary disease
- •- Second or third degree atrioventricular block
- •- Overt cardiac failure
- •- Cardiogenic shock
- •6. Subjects with a current diagnosis of cancer.
- •7. 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 results of the study.
- •8. Subjects with known or suspected drug or alcohol abuse.
- •Drug Therapies
- •9. Subjects with an anticipated need to initiate or modify medication
- •(systemic or topical) that is known to affect IOP (eg, beta-adrenergic
- •antagonists, alpha-adrenergic agonists, calcium channel blockers,
- •angiotensin-converting enzyme [ACE] inhibitors, and angiotensin II
- •receptor blockers) during the first 3 months (90 days) of study
- •10. Subjects for whom concomitant use of medications may interact
- •with the safety or efficacy of a nitric oxide (NO)-donating compound
- •(eg, vasodilators such as Isordil® and BiDil®).
- •11. Subjects with known hypersensitivity or contraindications to
- •latanoprost, NO treatment, or any of the ingredients in the study
- •12. Subjects with known hypersensitivity or contraindications to timolol
- •maleate, other beta-adrenergic receptor antagonists, or any of the
- •ingredients in the study drugs.
- •13. Subjects who are expected to require treatment with ocular or
- •systemic corticosteroids during the study duration.
- •14. Subjects who are currently taking diclofenac (oral or topical) or who
- •are expected to require treatment with diclofenac (oral or topical)
- 另有 10 项未显示
研究者
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