Glaucoma
Conditions
Keywords
Glaucoma, IOP, AZARGA
Brief summary
The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.
Interventions
1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent. * 21 years of age or older. * Able to follow instructions and willing to attend required study visits. * Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye). * Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial. * Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Presence of other primary or secondary glaucomas not listed in inclusion criterion. * Presence of corneal dystrophies. * Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1. * Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. * Women of childbearing potential not using reliable means of birth control. * Women who are pregnant or lactating. * Participation in any other investigational study within 30 days prior to Visit 1. * Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial. * Severe allergic rhinitis * History of ocular herpes simplex. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success | Week 4 and Week 12 |
Countries
Germany
Outcome results
None listed