Open-angle Glaucoma (OAG), Ocular Hypertension (OHT)
Conditions
Keywords
Elevated IOP
Brief summary
The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.
Interventions
DRUGAL-54478 0.005%
DRUGAL-54478 Vehicle
Inactive ingredients used as a placebo comparator
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with either OAG or OHT. * Patients who are able to comply with the scheduled visits. * Patients who have had a physical exam within 6 months of the Screening Visit. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures. * Patients with extreme narrow angle with complete or partial closure. * Patients with a cup to disc ratio more than 0.8. * Patients with a severe central visual field loss in either eye. * Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation. * Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months. * Patients with best-correct visual acuity less than 20/80. * Patients who have had ocular infection or inflammation within the past 3 months. * Patients who have clinically relevant progressive retinal disease. * Patients who have severe illness or conditions. * Patients who have hypersensitivity to a prostaglandin analogu.e * Patients who are unable to safely discontinue all IOP-lowering medications during washout. * Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing | Day 14 |
Outcome results
None listed