PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)


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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

Primary Outcome Measures:

  • intraocular pressure (IOP) [ Time Frame: 90days ]

    Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg

Estimated Enrollment: 51
Anticipated Study Start Date: August 4, 2017
Estimated Study Completion Date: December 16, 2018
Estimated Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)
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

Drug: PRO-122

Posology: 1 drop every 12 hours for 90 days

Other Name: krytantek PF (Timolol, Brimonidine, Dorzolamide)

Other: Placebo1

1 drop of each dropper bottle every 12 hours for 90 days

Other: Placebo 2

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

Drug: Timolol eye drops

1 drop every 12 hours for 90 days

Other Name: Concomitant triple therapy

Drug: Dorzolamide-Timolol Ophthalmic

1 drop every 12 hours for 90 days

Other Name: Concomitant triple therapy

Drug: Brimonidine Ophthalmic Solution

1 drop every 12 hours for 90 days

Other Name: Concomitant triple therapy

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

Other: Placebo1

1 drop of each dropper bottle every 12 hours for 90 days

Other: Placebo 2

1 drop of each dropper bottle every 12 hours for 90 days

Drug: Krytantek

Posology: 1 drop every 12 hours for 90 days

Number of patients: 51 subjects divided into 3 groups (17 subjects per group)

Diagnosis and main inclusion criterion:

Diagnosis: Primary open-angle glaucoma or ocular hypertension

Main criteria:

  • Patients of either sex
  • Average intraocular pressure (IOP) ≤ 36 mm/Hg
  • Previous management with ocular hypotensive medications ≥ 2 months, without achieving control (target IOP)
  • Age ≥ 18 years
  • Informed consent

Test product, dosage and route of administration:

  • PRO-122. Preservative-free ophthalmic solution of timolol 0.5% / brimonidine 0.2% / dorzolamide 2% Manufactured by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. + Placebo + Placebo
  • Dosage: 1 drop every 12 hours
  • Route of administration: ophthalmic

Treatment duration: 90 days

Evaluation criteria:

Efficiency (non-inferiority):

  • IOP decrease

Safety:

Tolerability:

  • Ocular comfort index

Statistical methodology:

The data will be expressed with measures of central tendency: mean and standard deviation for quantitative variables. The qualitative variables will be presented in frequencies and percentages. Statistical analysis will be done by means of a Kruskal-Wallis test for quantitative variables. The difference between qualitative variables will be analyzed using an square chi An alpha ≤ 0.05 would be considered as significant.