Glaucoma, Ocular Hypertension
Conditions
Brief summary
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.
Interventions
DRUGAL-3862+timolol ophthalmic suspension
DRUGDorzolamide+timolol ophthalmic solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign informed consent; * Diagnosis of glaucoma or ocular hypertension; * On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy); * IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye; * Pregnant, nursing, or not using highly effective birth control methods; * Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study; * History of bronchial asthma or severe chronic obstructive pulmonary disease; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a stated preference for either study medication | Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Mean ocular discomfort score | Day 1, 1 minute after drop instillation |
Outcome results
None listed