Primary Open-angle GlaucomaPhase 3PRO-122LATAMNCT03193333
PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
A Phase 3 study testing PRO-122, Timolol eye drops and Dorzolamide-Timolol Ophthalmic in people with Primary Open-angle Glaucoma, run by Laboratorios Sophia S.A de C.V. at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- PRO-122, Timolol eye drops and Dorzolamide-Timolol Ophthalmic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Nov 2017to 30 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 28Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
Read the 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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- PRO-122, Timolol eye drops, Dorzolamide-Timolol Ophthalmic, Brimonidine Ophthalmic Solution, Placebo1
- Keywords
- glaucoma, primary open-angle glaucoma, Ophthalmic antihypertensives, Krytantek Ofteno®., timolol, brimonidine, dorzolamide
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-122Drug
Also called krytantek PF (Timolol, Brimonidine, Dorzolamide)
Posology: 1 drop every 12 hours for 90 days
Timolol eye dropsDrug
Also called Concomitant triple therapy
1 drop every 12 hours for 90 days
Dorzolamide-Timolol OphthalmicDrug
Also called Concomitant triple therapy
1 drop every 12 hours for 90 days
Brimonidine Ophthalmic SolutionDrug
Also called Concomitant triple therapy
1 drop every 12 hours for 90 days
Placebo1Other
1 drop of each dropper bottle every 12 hours for 90 days
Placebo 2Other
1 drop of each dropper bottle every 12 hours for 90 days
KrytantekDrug
Posology: 1 drop every 12 hours for 90 days
| Study group | Role | What they receive |
|---|---|---|
| PRO-122 group | Experimental | 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 Receives: Drug: PRO-122; Other: Placebo1; Other: Placebo 2 |
| Concomitant triple therapy group | Active comparator | 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 Receives: Drug: Timolol eye drops; Drug: Dorzolamide-Timolol Ophthalmic; Drug: Brimonidine Ophthalmic Solution |
| Krytantek Ofteno Group | Active comparator | 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 Receives: Other: Placebo1; Other: Placebo 2; Drug: Krytantek |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start6 Nov 2017
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Why it stopped: Sponsor's prerogative since initial purpose for study shifted according to business strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193333
- Sponsor's protocol ID
- SOPH122-0316/III
- Acronym
- PRO-122LATAM
- Status last verified
- Mar 2025
- First submitted
- 19 Jun 2017
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belalcazar S, Tornero-Jimenez A, Mejia-Morales C, Olvera-Montano O, Munoz-Villegas P. Assessment of the Effectiveness, Tolerability, and Safety of the Preservative-Free Fixed Combination of Timolol, Dorzolamide, and Brimonidine Compared to Separate Therapies in Patients with Glaucoma, a Randomized Controlled Trial. Clin Ophthalmol. 2026 Feb 19;20:580973. doi: 10.2147/OPTH.S580973. eCollection 2026.
PubMed 41737851
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03193333
- Acronym / sponsor ID
- PRO-122LATAM / SOPH122-0316/III
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- glaucoma, primary open-angle glaucoma, Ophthalmic antihypertensives, Krytantek Ofteno®., timolol, brimonidine, dorzolamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's prerogative since initial purpose for study shifted according to business strategy.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial
| Arm | Type | Receives |
|---|---|---|
| PRO-122 group | Experimental | Drug: PRO-122, Other: Placebo1, Other: Placebo 2To 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 |
| Concomitant triple therapy group | Active comparator | Drug: Timolol eye drops, Drug: Dorzolamide-Timolol Ophthalmic, Drug: Brimonidine Ophthalmic SolutionImot 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 |
| Krytantek Ofteno Group | Active comparator | Other: Placebo1, Other: Placebo 2, Drug: KrytantekTo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-122Also: krytantek PF (Timolol, Brimonidine, Dorzolamide)Posology: 1 drop every 12 hours for 90 days | Drug | PRO-122 group |
| Timolol eye dropsAlso: Concomitant triple therapy1 drop every 12 hours for 90 days | Drug | Concomitant triple therapy group |
| Dorzolamide-Timolol OphthalmicAlso: Concomitant triple therapy1 drop every 12 hours for 90 days | Drug | Concomitant triple therapy group |
| Brimonidine Ophthalmic SolutionAlso: Concomitant triple therapy1 drop every 12 hours for 90 days | Drug | Concomitant triple therapy group |
| Placebo11 drop of each dropper bottle every 12 hours for 90 days | Other | Krytantek Ofteno Group, PRO-122 group |
| Placebo 21 drop of each dropper bottle every 12 hours for 90 days | Other | Krytantek Ofteno Group, PRO-122 group |
| KrytantekPosology: 1 drop every 12 hours for 90 days | Drug | Krytantek Ofteno Group |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Sponsor's prerogative since initial purpose for study shifted according to business strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 41737851Belalcazar S, Tornero-Jimenez A, Mejia-Morales C, Olvera-Montano O, Munoz-Villegas P. Assessment of the Effectiveness, Tolerability, and Safety of the Preservative-Free Fixed Combination of Timolol, Dorzolamide, and Brimonidine Compared to Separate Therapies in Patients with Glaucoma, a Randomized Controlled Trial. Clin Ophthalmol. 2026 Feb 19;20:580973. doi: 10.2147/OPTH.S580973. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo Baiza, MD study director
Laboratorios Sophia S.A de C.V.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRO-122, Timolol eye drops and Dorzolamide-Timolol Ophthalmic in people with Primary Open-angle Glaucoma, run by Laboratorios Sophia S.A de C.V. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's prerogative since initial purpose for study shifted according to business strategy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (IOP) (time frame: 90days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.