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Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide

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Laboratorios Sophia

Status and phase

Completed
Phase 2

Conditions

Ocular Hypertension
Primary Open Angle Glaucoma

Treatments

Drug: dorzolamide-timolol-brimonidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01062971
SOPHIA-PRO-122

Details and patient eligibility

About

To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

Full description

This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.

Enrollment

124 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
  • Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

Exclusion criteria

  • Clinically relevant ophthalmic or systemic conditions may be excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

124 participants in 2 patient groups

A
Active Comparator group
Description:
IOP Dorzolamide-Timolol-Brimonidine group
Treatment:
Drug: dorzolamide-timolol-brimonidine
B
Active Comparator group
Description:
IOP dorzolamide-timolol group
Treatment:
Drug: dorzolamide-timolol-brimonidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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