None listed
Conditions
Interventions
dorzolamide Type of group
Dorzolamide 2% three times daily in the eye (s) of the study, in the morning.
Group name:timolol SG Type of group
Timolol will be administered daily in gel-forming solution (SG) in the eye (s), in the morning.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients under 6 years old (approximately half will be 2 years but 22 mmHg in one or both eyes. 3. Discontinuation of topical or systemic ocular hypotensive medication for at least 24 hours before Study Day 1 4. Complete physical examination within 3 months prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1. The patient is currently using contact lenses for continuous use 2. Antecedents or evidence of goniotomy or trabeculotomy within the month prior to the start of the study, implant surgery or filtration within 3 months prior to the start of the study or cyclodestructive surgery within 3 months prior to the start of the study. 3. Antecedents or evidence of significant ocular trauma within 3 months prior to the start of the study. 4. Evidence of inflammation and / or acute or recent ocular infection within the month prior to the start of the study. 5. Chronic conjunctivitis, chronic keratitis or lacrimal deficiency. 6. Non-ocular systemic or concomitant topical medication known to affect intraocular pressure 7. Participation in a study that involves a research drug within the previous 4 weeks. 8. History of hypersensitivity to any component of dorzolamide or ophthalmic solutions of timolol SG; severe or serious hypersensitivity known to sulfonamides. 9. Any contraindication to the use of timolol ophthalmic solutions SG 10. History or evidence of impaired renal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:proportion of patients discontinuing therapy due to an adverse experience related to the drug that occurs before completing the 3-month therapy. Measure:safety Timepoints:At 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Average percentage change of the Baseline (Study Day 1) in the intraocular pressure of the eye designated as the worst eye Measure:Efficacy Timepoints:12 weeks | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed