| Eligibility |
Inclusion Criteria:
1. Willing and able to understand and sign an informed consent form prior to any study
related procedures.
2. Able to administer or have a caregiver accurately administer an eye drop.
3. Have POAG or OHT in both eyes that requires therapy for IOP and is adequately
controlled, in the opinion of the Investigator, on no more than 2 ocular hypotensive
medications (fixed dose combinations count as 2 medications). Subjects with OHT on no
ocular hypotensive medication are acceptable. Presence of POAG in one eye and OHT in
the fellow eye is acceptable.
3. Able, in the opinion of the Investigator, to safely discontinue use of ocular
hypotensive medications, if applicable, and undergo the appropriate required washout period
for ocular hypotensive medications prior to Visit 3/Qualification/Baseline.
4. At Visit 3/Qualification/Baseline, at least one eye must have unmedicated (post washout)
IOP = 22 and = 34 mm Hg at 8:00 AM and = 18 and = 34 mm Hg at 10:00 AM and 4:00 PM in the
same eye(s) qualifying at the Visit 3 8:00 AM time point. The IOP must be at least 22 mm Hg
at each consecutive measurement at the 8:00 AM time point.
5. No significant VF (visual field) loss, defined as a mean deviation in either eye greater
than - 12 dB or a central point of fixation < 5 dB in either eye. If the VF performed at or
within 90 days prior to Visit 1 does not meet study required parameters, it may be repeated
(test should be prior to randomization at Visit 3/Qualification/Baseline).
6. Best corrected visual acuity (BCVA) of +0.6 logMAR or better in both eyes at Visit
1/Screening and Visit 3/Qualification/Baseline.
7. Central corneal thickness = 480 and = 600 µm in both eyes. Pachymetry within 90 days
prior to Screening is acceptable.
8. Shaffer gonioscopic grade = 3 (in at least 3 quadrants) in both eyes. Gonioscopy within
90 days prior to randomization is acceptable.
9. Female subjects must be 1-year postmenopausal, surgically sterilized (total
hysterectomy, bilateral oophorectomy or bilateral tubal ligation > 90 days prior to Visit
1/Screening), or women of childbearing potential with a negative urine pregnancy test at
Visit 1/Screening and Visit 3/Qualification/Baseline who are not breastfeeding or planning
a pregnancy during the study. Women of childbearing potential must use an acceptable form
of contraception throughout the study. Acceptable methods include the use of at least one
of the following:
- Intrauterine (IUD) device
- Hormonal contraceptive (oral, injection, patch, implant, ring); subjects must have
been on the same hormonal contraceptive for = 90 days prior to Visit 1/Screening
- Double barrier method (spermicide used with either a condom or diaphragm)
- Abstinence
Exclusion Criteria:
Ocular
1. Intraocular pressure ? 34 mm Hg in either eye at Visit 1/Screening, Visit 2/Washout
Safety Check, or Visit 3/Qualification/Baseline.
2. Other forms of glaucoma in either eye, e.g., congenital glaucoma, closed-angle
glaucoma, uveitic glaucoma, pseudoexfoliation or pigment dispersion syndrome, or
history of angle closure. Narrow angles treated with peripheral iridotomy are allowed
if at least 4 months status post iridotomy.
3. Current or recent (within 30 days prior to Visit 1/Screening) clinically significant
ocular infection or inflammation, in the opinion of the Investigator, in either eye.
4. History of conjunctivitis within 90 days prior to Visit 1/Screening, or history of
herpes simplex or herpes zoster in either eye.
5. Clinically significant ocular disease, in the opinion of the Investigator, in either
eye (including, but not limited to corneal edema, uveitis, severe dry eye,
proliferative diabetic retinopathy or macular degeneration) that might interfere with
the study, confound study results, or put the subject at increased risk.
6. Have a cup-to disc (CD) ratio > 0.8 at Visit 1/Screening in either eye.
7. Intravitreal steroid injections within 6 months prior to Visit 1/Screening.
Subconjunctival or subtenon steroid injections within 90 days prior to Visit
1/Screening.
8. Use of topical ocular medications within 30 days prior to Visit 1/Screening other than
ocular hypotensive medications and medications used as part of an eye examination.
Artificial tears may be used during this period provided the use is not required for
severe dry eye disease.
9. Clinically significant ocular trauma or incisional ocular surgery (including routine
cataract surgery) in either eye within 6 months prior to Visit 1/Screening. Glaucoma
filtering surgery, or minimally invasive glaucoma surgery within 12 months prior to
Visit 1/Screening. Laser surgery for IOP reduction within 6 months prior to Visit
1/Screening. Non-incisional ocular surgery or non-glaucomatous laser treatment within
90 days prior to Visit 1/Screening.
10. Refractive surgery in either eye (i.e., radial keratotomy, photorefractive keratectomy
[PRK], laser-assisted in situ keratomileusis [LASIK], corneal cross-linking, limbal
relaxing incision) within 6 months prior to Visit 1/Screening.
11. Any ocular (e.g., corneal) abnormality preventing accurate assessment of IOP.
12. Contact lens wear within 1 week prior to Visit 1/Screening or unwillingness to
discontinue wear of contacts lenses prior to and during the study period.
13. Aphakia.
General
14. Pregnancy or lactation.
15. Known hypersensitivity or contraindication to ß-blockers (i.e., chronic obstructive
pulmonary disease, bronchial asthma, unstable or abnormally low blood pressure or
heart rate, second or third degree heart block or congestive heart failure, severe or
unstable diabetes mellitus) that in the opinion of the Investigator may put the
subject at risk from a topical ocular beta-blocker.
16. Have a condition or be in a situation which, in the Investigator's opinion, may put
the subject at significant risk, confound study results, or interfere with the
subject's participation in the study.
17. Clinically significant systemic disease (myasthenia gravis, hepatic, renal, endocrine,
or cardiovascular disorders) that in the opinion of the Investigator might interfere
with the study.
18. Use of systemic beta-adrenergic antagonists unless the dosage has been stable for 1
month prior to Visit 1/Screening and is expected to remain stable through the study
period.
19. Use of systemic (oral, injectable, inhaled) or topical steroids within 30 days prior
to Visit 1/Screening; topical dermatologic or intranasal steroids are acceptable
provided the usage meets the criteria outlined in the Summary of Prohibited
Medications and Procedures in the protocol.
20. Contraindication to the use of timolol, nebivolol, or any of the components of the
investigational products.
21. Changes to systemic medication that could have an effect on IOP within 28 days prior
to Visit 3/Qualification/Baseline.
22. Participation in any study of an investigational product within 30 days prior to Visit
1/Screening.
23. History of substance abuse within 1 year prior to Visit 1/Screening.
24. Screening and enrollment of employees or relatives of employees of the clinical site.
|
