Subjects are dosed once daily with either TRAVATAN®Z or LUMIGAN® at 8PM for 6 weeks and then
are switched for a further 6 weeks to the other product either TRAVATAN®Z or LUMIGAN®. The
primary efficacy variable: To demonstrate non-inferiority in the Intraocular Pressure (IOP)
lowering efficacy of travoprost 0. 004% (TRAVATAN® Z) to that of bimatoprost 0. 01% after 6
weeks of treatment. Secondary efficacy variable: To detect a difference in IOP lowering
efficacy of travoprost 0. 004% (TRAVATAN® Z) and bimatoprost 0. 01% measured at individual
time points post dose after 6 weeks of treatment.
Inclusion Criteria:
1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension
(OHT) in at least one eye .
3. Baseline IOPs ≥ 24 and <36 mmHg in the study eye at 8 AM ± 30 min after IOP lowering
medication washouts (5 days for miotics and carbonic anhydrase inhibitors, 14 days
for adrenergic agonists and 28 days for β-blockers and prostaglandin analogs, and
fixed combination drugs) on two separate eligibility visits.
4. After the washout period, must have IOPs considered to be safe in both eyes, in such
a way that should assure clinical stability of vision and the optic nerve throughout
the study period.
5. In the eye that is not included in the study, the IOP should be able to be controlled
on no therapy or on the study medicine alone.
6. Must be willing to discontinue the use of all other IOP lowering medications prior to
receiving the study medication and for the duration of the study.
7. Must be able to follow instructions, self instill study article and be willing and
able to attend all study visits.
8. Must have best corrected visual acuity of < 20/200 in each eye.
9. An Ethics Committee reviewed and approved informed consent form must be read,
signed, and dated by the participating subject, as well as signed and dated by the
individual obtaining the informed consent
Exclusion Criteria:
1. Known medical history of allergy, hypersensitivity or poor tolerance to any
components of the preparations to be used in this study
2. Any abnormality preventing applanation tonometry in either eye.
3. Corneal dystrophies.
4. Any opacity or subject uncooperativeness that restricts adequate examination of the
anterior chamber of either eye.
5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
eye.
6. Dry eye or keratoconjunctivitis sicca which has been, or is currently being, treated
with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular
corticosteroids.
7. Intraocular conventional or laser surgery >3 months prior to consent
8. Risk of visual field or visual acuity worsening as a consequence of participation in
the study, in the investigator's best judgment.
9. Progressive retinal or optic nerve disease from any cause.
10. A history of, or at risk for uveitis or cystoid macular edema (CME).
11. Use of any systemic medications known to affect IOP which have not been on a stable
course for at least 7 days prior to Screening or an anticipated change in dosage
during the course of the study.
12. Any clinically significant, serious, or severe medical condition.
13. Women of childbearing potential not using reliable means of birth control.
14. Women who are pregnant or lactating
15. Subjects who cannot safely undergo the washout period of 3 days ±1 day to 28 days ± 1
day prior to being enrolled/randomized.
16. A condition, which in the opinion of the Principal Investigator, would interfere with
optimal participation in the study, or which would present a special risk to the
subject.
17. Participation in any other study within 30 days prior to Screening.
18. Use of any systemic (oral), injectable or topical steroids
