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 – APOLLO Study
- Conditions
- Open-Angle Glaucomaor Ocular HypertensionTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-000552-18-CZ
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 393
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
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
- 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 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.
Ocular exclusion criteria:
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.
23. Subjects with traumatic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method