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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- intraocular pressure (IOP)
Study Overview
Brief 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
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Blinding will be performed by the personnel assigned by the Laboratorios Sophia S.A. de C.V. Clinical Operations Management. The blinding will consist in the elimination of the primary label (commercial) for Krytantek Ofteno® and the triple concomitant therapy and the placement of a label identical to those of the other interventions. Since the bottles in which Krytantek Ofteno® and the concomitant therapies are different in color and cap shape to the ones used for the placebo and the PRO-122, a masking will be performed in the primary packaging, which shall be identical for all three interventions.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •General criteria
- •Pregnant, breastfeeding or planning to get pregnant women.
- •Women of childbearing age and who do not intake a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- •Participation in another clinical research study greater or equal 30 days before the screening visit.
- •People who cannot comply with their attendance at appointments or with all the - Protocol requirements
- •Medical and therapeutic criteria:
- •Anterior chamber angle grade less than 2 of Shaffer rating.
- •Excavation of optic nerve greater than 0.80 horizontal or vertical (ratio cup-disc)
- •Serious loss of central visual field in any eye (sensitivity less or equal to 10 decibels in greater or equal to 2 of 4 points of the visual field test close to the fixation point)
- •People not able to safely suspend ocular hypotensives drug products for the washout period according to the PI judgement.
- •Chronic, recurrent, or active ocular inflammatory diseases (e.g. uveitis, scleritis, keratitis, herpetic) in any eye.
- •Eye trauma less or equal to 6 months prior to the study
- •Eye infection / inflammation less or equal to 3 months prior to the study
- •Clinically significant or progressive retinal disease (e.g. degenerations, diabetic retinopathy, retinal detachment)
- •Ability Visual 20/200 or worse in any of the eyes.
- •Subject with only one eye
- •Eye diseases that contraindicate the use of Beta-blocker (BB) Alpha-adrenergic agonist (AA) or Carbonic anhydrase inhibitors (CAIs)
- •Intraocular surgery less or equal to 6 months prior to the study
- •Laser intraocular surgery less or equal to 3 months prior to the study
- •Any abnormality preventing reliable applanation tonometry
- •Unstable or uncontrolled cardiovascular disease
- •Chronic pulmonary disease (e.g. bronchial asthma)
- •Any condition or illness that do not fit the subject for the study according to the PI judgment.
- •Use of high doses of salicylate (1 g daily) less or equal to4 weeks before the eligibility visit
- •In treatment with psychotropic medications that increase the adrenergic response
- •Known hypersensitivity to BB medications (e.g. timolol), AA (e.g. brimonidine) and CAI (e.g. dorzolamide), sulfonamide derivatives, or any of the components of the study drugs
- •Concomitant use of monoamine oxidase inhibitors
- •Systemic or topical use of corticosteroids
Arms & Interventions
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
Intervention: Dorzolamide-Timolol Ophthalmic (Drug)
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
Intervention: PRO-122 (Drug)
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
Intervention: Placebo1 (Other)
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
Intervention: Placebo 2 (Other)
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
Intervention: Krytantek (Drug)
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
Intervention: Placebo1 (Other)
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
Intervention: Placebo 2 (Other)
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
Intervention: Brimonidine Ophthalmic Solution (Drug)
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
Intervention: Timolol eye drops (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported