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

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ClinicalTrials.gov Identifier: NCT03193333
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Drug: PRO-122 Drug: Timolol eye drops Drug: Dorzolamide-Timolol Ophthalmic Drug: Brimonidine Ophthalmic Solution Other: Placebo1 Other: Placebo 2 Drug: Krytantek Phase 3

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

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:

  • Best corrected visual acuity
  • Cup-to-disc ratio
  • Visual fields determined by computerized perimetry
  • Central corneal thickness determined by pachymetry
  • Ocular surface integrity, including:

    • Conjunctival hyperemia
    • Chemosis
    • Fluorescein staining
  • Density of goblet cells
  • Adverse events

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial
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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193333


Contacts
Contact: Ricardo Llamas, PhD (33)30014200 ext 1259 ricardo.llamas@sophia.com.mx
Contact: Oscar Olvera, MD (33)30014200 ext 1074 oscar.olvera@sophia.com.mx

Locations
Mexico
MD. Victoria Eugenia Sanchez Castellanos Recruiting
Zapopan, Jalisco, Mexico, 44960
Contact: Victoria Sanchez Castellanos, MD    +5213339152222    victoriaoftalmo@hotmail.com   
Contact: Miguel Montes Salcedo, MD    +5213339152222    doctorlasik@yahoo.com.mx   
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
Study Director: Leopoldo Baiza, MD Laboratorios Sophia S.A de C.V.
More Information

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT03193333     History of Changes
Other Study ID Numbers: SOPH122-0316/III
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laboratorios Sophia S.A de C.V.:
glaucoma
primary open-angle glaucoma
Ophthalmic antihypertensives
Krytantek Ofteno®.
timolol
brimonidine
dorzolamide

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Dorzolamide
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors