None listed
Conditions
Interventions
Group 1 Type of group
Latanoprost Ophthalmic drops Typically 1 drop every morning for 21 days
Group name:Group 2 Type of group
CF (Latanofrost + Timolol) Ophthalmic drops Typically 1 drop every morning for 21 days
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Man or woman> 18 years old • Unilateral or bilateral open-angle glaucoma, pigmentary or capsular glaucoma or ocular hypertension with open anterior chamber angle. • That you have used latanoprost 50 ug / mL (QD) with or without additional monotherapy of medication to lower IOP for at least 4 weeks in the current treatment prior to selection. • PIO> 21mmHg • Better correction of visual acuity greater than 0.1 (20/200). • Informed informed consent in the selection visit.
Exclusion criteria
Exclusion criteria: • Closed / barely open angle of the anterior chamber or a history of acute angle closure • Among patients currently on timolol therapy or with a previous history of timolol therapy, a failure to demonstrate at least a partial response to timolol. (A partial response is defined as a decrease of at least 4 mmHg from the IOP of the patient after initial treatment with timolol) • Eye surgery or transculoplasty with argon laser (TLA) within three months prior to the screening visit for the study eye. (For a companion eye that does not meet all of the above inclusion criteria, the appropriate time interval after eye surgery or TLA is at the discretion of the investigator). • Inflammation / eye infection occurring within three months prior to the screening visit. • Hypersensitivity to benzalkonium chloride or any other component of study drug solutions. • Any condition that comes from a reliable flattening tonometry. • Other conditions or abnormal eye symptoms that prevent the patient from entering the study, according to the investigator´s judgment. • Other medical conditions in which treatment with p-blocking agents is contraindicated, such as heart failure, sinus bradycardia, second or third degree atrioventricular block, bronchial asthma or its corresponding history, and obstructive pulmonary disease. • Women breastfeeding or pregnant. • Women with pregnancy potential not using adequate contraceptive methods at least three months before randomization and / or not being willing to use adequate contraceptive methods during the study period and adding one month after the last dose of the study medication. • Not being able to adhere to the treatment / visits plan. • Participation in any other clinical study within a period of one month prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:IOP measurement Measure:Proportion of patients with a decrease in IOP of 18 mmHg or less Timepoints:21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:IOP measurement Measure:Proportion of patients with each of the following IOP decreases: at least 3 mmHg, at least 4 mmHg, and at least 5 mmHg at 0800 after three weeks (21 days) of treatment. Timepoints:21 days ; Outcome name:For each event, the following information will be included in the tabulation: Type of event, duration of the event, severity, seriousness, action taken, result and evaluation of causality. Measure:Adverse events Timepoints:During treatment | — |
Outcome results
None listed