EUCTR2013-000553-45-DE进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 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 drug).
- •- 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]):
- •- mean/median IOP = 26 mmHg at a minimum of 1 time point, = 24 mmHg at a minimum of 1 time point, and = 22 mmHg at 1 time point in the same eye, and
- •- IOP = 36 mmHg at all 3 measurement time points in both eyes.
- •8. Subjects with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of ap
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).
- •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.
- •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 treatment.
- •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 drugs.
- •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 first 3 months (90 days) of the study.
- •14. Subjects who are currently taking diclofenac (oral or topical) or who are expected to require treatment with diclofenac (oral or topical) during the first 3 months (90 days) of the study.
- •15. Subjects who are in need of or expected to require any other topical or systemic treatment of OAG or OHT during the study duration.
- •16. Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
- •17. Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
- •18. Subjects with a central corneal thickness greater than 600 µm in either eye.
- •19. Subjects with any condition that prevents reliable applanation tonometry (eg, significant corneal surface abnormalities) in either eye.
- •20. Subjects with advanced glaucoma with a cup/disc ratio greater than 0.8, a history of split fixation, or a field loss threatening fixation in either eye.
- •21. Subjects with any condition that prevents clear visualization of the fundus in either eye.
- •22. Subjects who are mo
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