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
- Conditions
- Open-Angle Glaucomaor Ocular HypertensionTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-000553-45-GB
- 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 log
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).
Surgery
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
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 study duration.
14. Subjects who are currently taking diclofenac (oral or topical) or who
are expected to require treatment with diclofenac (oral or topical)
during the study duration.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate that the mean intraocular<br>pressure (IOP) reduction after 3 months (90 days) of treatment with<br>BOL-303259-X 0.024% (latanoprostene bunod) once daily (QD) is<br>non-inferior to timolol maleate 0.5% twice daily (BID).;Secondary Objective: The secondary objective is to demonstrate the superiority of<br>BOL-303259-X 0.024% QD to timolol maleate 0.5% BID. This<br>assessment will be performed if the non-inferiority of<br>BOL-303259-X 0.024% QD to timolol maleate 0.5% BID is determined.;Primary end point(s): The primary efficacy endpoint is the IOP in subjects’ study eye measured<br>at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4 (Week 2),<br>Visit 5 (Week 6), and Visit 6 (Month 3).;Timepoint(s) of evaluation of this end point: Efficacy evaluations will be made at Visit 4 (Week 2), Visit 5 (Week 6),<br>and Visit 6 (Month 3), with ongoing safety evaluations made at Visit 7<br>(Month 6).
- Secondary Outcome Measures
Name Time Method