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

Primary Open-angle Glaucoma Clinical Trial

— PRO-122LATAM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03193333
• Other study ID #: SOPH122-0316/III
• Status: Recruiting
• Phase: Phase 3
• Start date: November 6, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Laboratorios Sophia S.A de C.V.
• Contact: Ricardo Llamas, PhD
• Phone: (33)30014200
• Email: ricardo.llamas[@]sophia.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Drug:
• PRO-122
Posology: 1 drop every 12 hours for 90 days
• Timolol eye drops
1 drop every 12 hours for 90 days
• Dorzolamide-Timolol Ophthalmic
1 drop every 12 hours for 90 days
• Brimonidine Ophthalmic Solution
1 drop every 12 hours for 90 days

Other:
• Placebo1
1 drop of each dropper bottle every 12 hours for 90 days
• 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

Locations

Country	Name	City	State
Colombia	MD. Sandra Belalcazar Rey	Bogotá	Bogotá D.C.
Mexico	MD. Victoria Eugenia Sanchez Castellanos	Zapopan	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Sophia S.A de C.V.

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure (IOP)	Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg	90days