A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma

Who is this study for? Patients with Glaucoma
Status: Terminated
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Objectives: To evaluate the non-inferiority in the intraocular pressure decrease of the preservative-free ophthalmic solution PRO-122, manufactured by Laboratorios Sophia S.A. de C.V., versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma and/or IOP. Hypothesis: The mean (average) value of the IOP final absolute reduction in the experimental group (PRO-122) is not lower, considering a lower limit of 1 mmHg, compared to the IOP mean absolute reduction of the standard group (concomitant therapy). Methodology: A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed consent

• Age greater or equal to 18 years

• Both sexes

• Women of childbearing age with birth control method

• Diagnosis of Primary open-angle glaucoma (according to the Guidelines of the Preferred Practice Pattern of the American Academy of Ophthalmology) or ocular hypertension (OHT)

• Intraocular pressure (IOP) not controlled with dual therapy according to the principal investigator (PI) judgment.

• IOP on the selection visit at 9 am, after the washing period, from 21 - 36 mmHg in at least one eye.

Locations
Other Locations
Colombia
MD. Sandra Belalcazar Rey
Bogotá
Mexico
MD. Victoria Eugenia Sanchez Castellanos
Zapopan
Time Frame
Start Date: 2017-11-06
Completion Date: 2024-10-30
Participants
Target number of participants: 51
Treatments
Experimental: PRO-122 group
To validate the 3 flasks of the triple therapy will be used 1 bottle with the three active principles (PRO-122) and two placebos and thus comply with the masking.~Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. preservative free.~Pharmaceutical form: Ophthalmic solution~Made by: Laboratorios Sophia, S.A. de C.V.~Posology: 1 drop every 12 hours for 90 days~Description of the solution: clear, visibly particle free, slightly yellow solution, preservative free~* Package description: 5 m multidose dropper bottle.~ * Placebo (for~* Two pieces of approved placebo. Administered in 2 multidose dropper bottles.~* Posology: 1 drop of each dropper bottle every 12 hours for 90 days
Active_comparator: Concomitant triple therapy group
Imot Ofteno~Drug substance: Timolol 5 mg/mL~Pharmaceutical form: Ophthalmic solution~Made by Laboratorios Sophia S.A. de C.V.~Alphagan~Drug substance Brimonidine 2 mg/mL~Pharmaceutical form: Ophthalmic solution~Made by: Allergan, Inc.~Trusopt~Drug substance: Dorzolamide 20 mg/mL~Pharmaceutical form: Ophthalmic solution~Made by: Merck Sharp and Dohme Corp.~Posology: 1 drop every 12 hours for 90 days
Active_comparator: Krytantek Ofteno Group
To validate the three flasks of the triple therapy will be used 1 bottle with the three active principles (Krytantek) and two placebos and thus comply with the masking.~Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL.~Pharmaceutical form: Ophthalmic solution~Made by: Laboratorios Sophia, S.A. de C.V.~Posology: 1 drop every 12 hours for 90 days~Description of the solution: clear, visibly particle free, slightly yellow solution Package description: 5 m multidose dropper bottle.~Placebo (for two pieces of approved placebo. Administered in 2 multidose dropper bottles.~Posology: 1 drop of each dropper bottle every 12 hours for 90 days
Sponsors
Leads: Laboratorios Sophia S.A de C.V.

This content was sourced from clinicaltrials.gov