Open-angle Glaucoma or Ocular Hypertension

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) after initial and repeated administrations

bimatoprost SR/implant

bimatoprost

implant

10
15

Efficacy: Intraocular pressure measured by Goldmann applanation tonometry
Safety: Adverse events; ocular parameters as determined through assessment of visual acuity and visual field;
evaluation of macroscopic bulbar conjunctival hyperemia and iris color; assessment of endothelial cell density
and corneal thickness; IOP measurement, biomicroscopic and ophthalmoscopic examinations (including
gonioscopy with Bimatoprost SR implant assessment, optic disc examination, and dilated fundus examination);
and optical coherence tomography (OCT) of the macula

The following are requirements for entry into the study:
1. Male or female, ≥ 18 years of age
2. Written informed consent has been obtained
3. Written documentation has been obtained in accordance with the relevant country and
local privacy requirements, where applicable (eg, Written Authorization for Use and
Release of Health and Research Study Information [US sites] and written Data Protection
consent [EU sites])
4. Patient is willing to withhold his/her IOP-lowering treatments according to the study
requirements, and in the opinion of the investigator can do so without significant risk.
Note: If patients cannot discontinue their currently prescribed therapy for up to 6 weeks
to meet the Washout period for study entry, the investigator may switch the patient’s
medication to one that requires a shorter washout interval during the washout of the
original medication (see Section 8.2 and Table 7).
5. Patient has the ability to understand and willingness to follow study instructions and is
likely to complete all required visits and procedures
6. A negative pregnancy test result for females of childbearing potential at Baseline
7. Diagnosis of either OAG (ie, primary, pseudoexfoliation, or pigmentary glaucoma) or
OHT in each eye and both eyes require IOP-lowering treatment (Note: diagnosis does
not have to be the same in both eyes)
8. In the investigator’s opinion, either eye can be treated adequately with topical ophthalmic
beta-blocker (eg, timolol) eye drops as the sole therapy
9. In the investigator’s opinion, either eye can be treated adequately with topical
prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan)
eye drops as the sole therapy
10. The iridocorneal angle inferiorly in both eyes must be open based on clinical gonioscopic
examination
11. Iridocorneal angle in the study eye must be confirmed as being qualified by Reading
Center AS-OCT assessment
12. At the Baseline visit, patient has been appropriately washed out of all IOP-lowering
medications
13. At the Baseline visit:
a. Hour 0 IOP in the study eye of ≥ 22 mm Hg and ≤ 32 mm Hg, and in the fellow eye
of ≥ 17 mm Hg and ≤ 32 mm Hg, with difference between eyes of ≤ 5 mm Hg
b. Hour 2 IOP in the study eye of ≥ 19 mm Hg and ≤ 32 mm Hg, and in the fellow eye
of ≥ 14 mm Hg and ≤ 32 mm Hg
14. Central Corneal Endothelial Cell Density by specular microscopy:
a. At Screening, a minimum endothelial cell density of 1800 cells/mm2
in at least one
eye by automated analysis
b. By Baseline: final central endothelial cell density in both eyes must be confirmed as
being qualified by Reading Center assessment
15. At the Baseline (Day -3 to -1) visit: best-corrected visual acuity (BCVA; Snellen
equivalent, by manifest refraction) of 20/50 or better in the study eye and 20/100 or
better in the fellow eye

The following are criteria for exclusion from participating in the study:
Non-ocular Criteria for Exclusion
1. Uncontrolled systemic disease
2. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of
childbearing potential and not using a reliable means of contraception during the study
(see Section 4.5.3)
3. Known allergy or sensitivity to any study medication or its components, any component
of the delivery vehicle, procedure-related materials, or diagnostic agents used during the
study (eg, topical anesthetic, dilating drops, fluorescein)
4. Contraindications to beta-blocker therapy, eg,
• Reactive airway disease including bronchial asthma or a history of bronchial asthma,
or severe chronic obstructive pulmonary disease
• Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree
atrioventricular block not controlled with pacemaker, overt cardiac failure, or
cardiogenic shock
5. Any condition which would preclude the patient’s ability to comply with study
requirements, including completion of the study
6. Patients who have a condition or are in a situation which, in the investigator's opinion,
may put the patient at significant risk, may confound the study results, or may interfere
significantly with the patient's participation in the study
7. Anticipated use of oral, intramuscular, or intravenous corticosteroids from 2 months prior
to the Baseline visit through Week 52
8. Concurrent or anticipated enrollment in an investigational drug or device study or
participation in such a study within 2 months prior to the Baseline visit through the final
study visit
9. Previous enrollment in Allergan Study 192024-041D
10. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of
the investigator). Note: Patients receiving pharmacologic blood thinners (eg, aspirin,
Coumadin) may be enrolled at the investigator’s discretion.
Ocular Criteria for Exclusion
11. In the investigator’s opinion, patient is nonresponsive to topical ophthalmic beta-blockers
and/or topical prostamides, prostaglandins, or prostaglandin analogs (eg, LUMIGAN,
Xalatan, Travatan)
12. History of a traumatic cataract and/or traumatic angle recession in the study eye
13. History of cataract surgery in the study eye resulting in anterior chamber intraocular lens
implant (IOL); phakic IOL; sulcus IOL; aphakia; or complications (eg, a posterior
capsular tear [with or without vitreous loss], iris trauma, etc)
14. Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the
6 months prior to treatment (Day 1) in the study eye
15. Any history of corneal graft, including partial grafts (eg, Descemet’s Stripping
Endothelial Keratoplasty [DSEK]; Descemet’s Membrane Endothelial Keratoplasty
[DMEK]) in the study eye
16. Incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or
limbal relaxing incisions in the study eye
17. Corneal or other ocular abnormalities in either eye that would preclude accurate readings
with an applanation tonometer, AS-OCT, specular microscope, and/or a contact
pachymeter, or could confound study results, eg, moderate to severe corneal dystrophy,
including Anterior Basement Membrane Disease (ABMD; ie, Map-Dot-Fingerprint
[MDF]) and guttata. Note: Mild ABMD or mild guttata are not exclusionary by clinical
examination if in the opinion of the investigator, the condition is stable and not likely to
cause corneal changes during the course of the clinical study period.
18. Any history of iris color changes associated with use of topical prostaglandins or
prostamides in either eye
19. Active or recurrent ocular disease in either eye (eg, uveitis, ocular infection, chronic
moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) or
sight-threatening diseases (eg, neovascular age-related macular degeneration [ARMD],
diabetic macular edema) that, in the opinion of the investigator, would put the patient at a
significant risk or would interfere with the interpretation of the study data. Note:
Patients with slowly progressive eye diseases (ie, mild cataracts, non-neovascular
ARMD) can be enrolled at the discretion of the investigator.
20. In the study eye, any history of external ocular or intraocular malignancy, and/or any
history of benign ocular neoplasia that, in the investigator’s opinion, resulted in clinically
significant ocular morbidity
21. History of herpetic ocular diseases (including herpes simplex virus and varicella zoster
virus) in the study eye
22. The following ocular surface findings:
a. Bulbar conjunctival hyperemia on either macroscopic or slit-lamp examination,
> +1(mild) in either eye at Baseline
b. Active ocular surface findings other than bulbar conjunctival hyperemia, on either
macroscopic or slit-lamp examination, > +1 (mild) at Baseline in the study eye
23. History of moderate or worse (≥ +2) bulbar conjunctival hyperemia due to marketed
prostaglandin, prostamide, or prostaglandin analog use in either eye
24. The following anticipated wearing of contact lenses during the study in either eye
(contact lens wear is allowed during the study, but is to be temporarily discontinued
before study visits, and before and after an Administration Day according to the
following):
a. Use of soft lenses should be discontinued at least 3 days prior to baseline
[Day -3 to -1], and use of rigid gas permeable or hard contact lenses should be
discontinued at least 1 week prior to Baseline.
b. Use of soft lenses should be discontinued at least 3 days and use of rigid gas
permeable or hard contact lenses should be discontinued at least 1 week prior to a
scheduled study visit or Administration Day visit
c. Use of contact lenses of any kind is prohibited within 1 week following any
Bimatoprost SR (or Sham) administration
25. Central corneal thickness of < 480 micrometers or > 620 micrometers in the study eye
26. Anticipated need for any incisional or laser ocular surgery in either eye within the first
52 weeks of the study duration
27. History of anatomically narrow angle resulting in evidence of angle changes, or any
history of closed angle glaucoma in either eye
Note: Historically narrow angled patients whose angle has been opened by
cataract surgery may be eligible for enrollment if they have no evidence of angle
abnormalities.
28. History of a peripheral iridotomy/iridectomy in the inferior 180° of the iris in the study
eye.
Note: Patients with a peripheral iridotomy/ iridectomy in the superior 180° of the
iris are eligible for study entry.
29. Any history of trabeculectomy or other types of glaucoma surgery, including a glaucoma
seton or aqueous bypass stents, in either eye.
30. History of laser trabeculoplasty within 6 months prior to screening in the study eye
31. Peripheral anterior synechiae (PAS) in the inferior iridocorneal angle on gonioscopic
examination at screening in either eye (Note: limited PAS resulting from previous laser
trabeculoplasty in the fellow eye are not exclusionary)
32. Visual field loss in either eye that, in the opinion of the investigator, is functionally
significant (eg, split fixation, field defect within the central 10 degrees that is visually
significant or likely to cause central visual impairment upon progression) or shows
evidence of progressive visual field loss within the year prior to Baseline (Note: Two
visual fields are required for qualification, one performed within the 10 months prior to
or at Screening, and one performed at Baseline or during the washout period using the
protocol-required testing method (see Protocol Procedure Manual). The same test
methodology should be used for all historical and study-related examinations for a given
patient.)
33. Evidence of macular edema on screening OCT evaluation or in medical history in either
eye
34. Use of any ocular corticosteroids from 2 months prior to the baseline exam or anticipated
use during the study period in either eye, except for use of postoperative topical ocular
corticosteroids from an Administration Day to Day 7 following an administration, as
described in Section 4.5.1 (Permissible Medications/Treatments)
35. Anticipated use of other topical ocular medications in either eye except as described in
Section 4.5.1 (Permissible Medications/Treatments).