Glaucoma, Open-AnglePhase 4PRO-122NCT04702789
Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.
A Phase 4 study testing Dorzolamide-timolol-brimonidine and latanoprost and Dorzolamide-timolol and latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Dorzolamide-timolol-brimonidine and latanoprost and Dorzolamide-timolol and latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 19 Oct 2021to 23 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with primary open-angle glaucoma (according to the Preferred Practice Pattern guidelines of the American Academy of Ophthalmology) or ocular hypertension, not controlled by a prostaglandin analogue or a β-blocker in the eye to be included in the study.
- Previous treatment for at least 30 days prior to the eligibility visit with a prostaglandin analogue or a β-blocker in the eye to be included in the study.
- Intraocular pressure measured by Goldmann tonometry ≥ 19 and ≤ 26 mmHg in the eye to be included in the study.
- Ability to voluntarily provide informed consent.
- Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
- Age ≥ 18 years.
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the clinical study.
- For women of reproductive age, not using a hormonal contraceptive method, intrauterine device, or bilateral tubal ligation.
- Anterior chamber angle < 2 in the Shaffer Classification or presence of peripheral anterior synechiae in the eye to be included in the study.
- Currently undergoing treatment with any systemic ocular hypotensive agent (e.g., mannitol, glycerin, isosorbide).
- Best Corrected Visual Acuity worse than 20/200 in the eye to be included in the study.
- Severe central visual field loss (sensitivity ≤ 10 dB in ≥ 2 of the 4 central points of the visual field fixation point) in the eye to be included in the study.
Show all 22Show fewer
- History of ocular surgery or laser eye procedure in the last 6 months in the eye to be included in the study.
- History of ocular trauma in the last 6 months in the eye to be included in the study.
- History of chronic uveitis in the eye to be included in the study.
- History of intraocular, periocular, retrobulbar, subconjunctival, or subtenon injection in the last 6 months in the eye to be included in the study.
- Patients with silicone, or who have had silicone in the anterior or posterior segment of the eye to be included in the study.
- Diagnosis of aphakia in the eye to be included in the study.
- Any corneal abnormality that decreases the reliability of Goldmann tonometry in the eye to be included in the study.
- Known hypersensitivity to the active ingredients used in the study (prostaglandin analogues, β-adrenergic blockers, α2-adrenergic agonists, carbonic anhydrase inhibitors).
- Diseases that contraindicate the use of the active ingredients used in the study (e.g., severe asthma or COPD, 2nd or 3rd degree atrioventricular block not controlled by a pacemaker, sinus bradycardia, manifest heart failure, Chronic Kidney - - Disease with a CrCl < 30 ml/min).
- Patients requiring the use of monoamine oxidase inhibitors (MAOIs), and patients treated with antidepressants affecting noradrenergic transmission (e.g., tricyclic antidepressants and mianserin).
- Patients who use, or have used in the last month, topical ocular steroids in the eye to be included in the study, or steroids via oral, intravenous, intramuscular, dermal, or intralesional routes.
- Have participated in another clinical research study within 30 days prior to signing the informed consent form (ICF).
- Have previously participated in this study.
- Have a history of drug addiction within the last two years prior to signing the ICF.
- Have any type of surgical intervention planned during the study period.
- Be or have an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is part of the research site personnel or the sponsor
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Servicios Médicos y de Investigación Clínica InspirePharma S. de R.L.de C.V.
Monterrey
About this study
Official title: Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Dorzolamide-timolol-brimonidine and latanoprost, Dorzolamide-timolol and latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorzolamide-timolol-brimonidine and latanoprostDrug
Also called PRO-122, Krytantek Ofteno PF®, Gaap Ofteno PF®
Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Krytantek Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
Dorzolamide-timolol and latanoprostDrug
Also called Eliptic Ofteno PF®, Gaap Ofteno PF®
Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Eliptic Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | Experimental | Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Krytantek Ofteno® (dorzolamide 2%, timolol 0.5% and brimonidine 0.2%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days). Receives: Drug: Dorzolamide-timolol-brimonidine and latanoprost |
| Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® | Experimental | Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Eliptic Ofteno® (dorzolamide 2% and timolol 0.5%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days). Receives: Drug: Dorzolamide-timolol and latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.
Measured: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Secondary outcomes (10)
Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
BCVA was compared between groups and between visits. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.
Measured: Days: -30 (± 2) (eligibility visit), 0 (basal visit [BV]), 14 (± 2) (first follow-up visit [V1]), 30 (± 2) (second follow-up visit [V2]) and 60 (± 2) (final visit [FV])
Optic Nerve Cup/Disc Ratio (Baseline Vist vs Final Visit)
Both clinical and imaging evaluation will be performed. For clinical evaluation, after the application of a topical ophthalmic mydriatic (tropicamide 0.8% / phenylephrine 5%), indirect ophthalmoscopy will be performed through the aid of a fundus lens in a slit lamp. For imaging, optic coherence tomography (OCT) will be used. Assessed and reported only for the basal visit and final visit.
Measured: Days: 0 (basal visit) and 60 (± 2) (final visit)
Mean Value in Nerve Fibers and Ganglion Cell Thickness
Spectral domain OCT is a non invasive tool that will be used to evaluate quantitatively the thickness of retinal nerve fibers and ganglion cell layers. The mean observed in the nerve fibers and ganglion cell thickness was calculated. This was assessed and reported only for the basal and final visit.
Measured: Days: 0 (basal visit) and 60 (± 2) (final visit)
Optic Nerve Image
Through a fundus camera a photograph will be taken to obtain a faithful record of any possible changes to the optic nerve head characteristics. Its classification as "small", "medium" or "large" relied on the expertise of the PI, the percentage of cases in each classification ("small", "medium" or "large") was reported. Assessed and reported only for the basal visit and final visit.
Measured: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
Central Corneal Thickness (CCT)
Measured through ultrasonic pachymetry, three assessments will be performed, these and its average will be recorded. Assessed and reported for the basal visit and final visit.
Measured: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Visual Fields
Visual fields will be assessed using standard automated SITA (Swedish Interactive Thresholding Algorithm) white-on-white perimetry performed with a Humphrey perimeter. To be considered reliable, fixation losses, false positives, and false negatives must be less than 20%.
The mean deviation (MD) was recorded, which is a measure of overall field loss. The standard deviation of the pattern was also recorded, which is a measure of focal loss or variability within the field. A higher score is a worse result.
The theoretical value or reported range for the average deviation is from +2.00 to -35 dB.
Measured: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Ocular Surface Integrity (Chemosis)
By means of a slit lamp chemosis will be evaluated. Chemosis will be evaluated as present (if conjunctiva separates from the sclera in ≥ 1/3 of the palpebral opening area or if it exceeds the eyelid's gray line) or absent. The number and percentage of participants in each category was reported.
Measured: Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)
Number of Adverse Events
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution.
Measured: Day: 75 (± 3) (safety call)
Changes in Ocular Comfort Index
Ocular Comfort Index (OCI) Questionnaire will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Measured: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Change in Ocular Surface Integrity (Conjunctival Hyperemia)
By means of a slit lamp conjunctival hyperemia will be evaluated. Conjunctival hyperemia will be graded according to Efron's scale (5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4)).
Measured: Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start19 Oct 2021
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Why it stopped: For interests of sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, multicenter with parallel groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702789
- Sponsor's protocol ID
- SOPH122-0420/IV
- Acronym
- PRO-122
- Status last verified
- May 2026
- First submitted
- 7 Jan 2021
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olvera-Montano O, Mejia-Morales C, Jauregui-Franco RO, Gomez-Mendez SC, Munoz-Villegas P. Maximum Tolerated Medical Therapy for Glaucoma: Fixed-Dose Combinations of Timolol, Dorzolamide, Brimonidine with Latanoprost Versus Timolol, Dorzolamide with Latanoprost. Clin Ophthalmol. 2025 Aug 22;19:2913-2925. doi: 10.2147/OPTH.S540312. eCollection 2025.
PubMed 40873654
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
- ClinicalTrials.gov ID
- NCT04702789
- Acronym / sponsor ID
- PRO-122 / SOPH122-0420/IV
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For interests of sponsor.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, multicenter with parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® | Experimental | Drug: Dorzolamide-timolol-brimonidine and latanoprostApplication of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Krytantek Ofteno® (dorzolamide 2%, timolol 0.5% and brimonidine 0.2%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days). |
| Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® | Experimental | Drug: Dorzolamide-timolol and latanoprostApplication of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Eliptic Ofteno® (dorzolamide 2% and timolol 0.5%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with primary open-angle glaucoma (according to the Preferred Practice Pattern guidelines of the American Academy of Ophthalmology) or ocular hypertension, not controlled by a prostaglandin analogue or a β-blocker in the eye to be included in the study.
- Previous treatment for at least 30 days prior to the eligibility visit with a prostaglandin analogue or a β-blocker in the eye to be included in the study.
- Intraocular pressure measured by Goldmann tonometry ≥ 19 and ≤ 26 mmHg in the eye to be included in the study.
- Ability to voluntarily provide informed consent.
- Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
Key exclusion criteria (22 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the clinical study.
- For women of reproductive age, not using a hormonal contraceptive method, intrauterine device, or bilateral tubal ligation.
- Anterior chamber angle < 2 in the Shaffer Classification or presence of peripheral anterior synechiae in the eye to be included in the study.
- Currently undergoing treatment with any systemic ocular hypotensive agent (e.g., mannitol, glycerin, isosorbide).
- Best Corrected Visual Acuity worse than 20/200 in the eye to be included in the study.
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 |
|---|---|---|
| Dorzolamide-timolol-brimonidine and latanoprostAlso: PRO-122, Krytantek Ofteno PF®, Gaap Ofteno PF®Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Krytantek Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days. | Drug | Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF® |
| Dorzolamide-timolol and latanoprostAlso: Eliptic Ofteno PF®, Gaap Ofteno PF®Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Eliptic Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days. | Drug | Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF® |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg. Assessed at the eligibility visit, basal visit, first follow-up visit, second follow-up visit, and final visit, reported only for first follow-up visit, second follow-up visit and final visit.
10 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit [BV]), 14 (± 2) (first follow-up visit [V1]), 30 (± 2) (second follow-up visit [V2]) and 60 (± 2) (final visit [FV])
Optic Nerve Cup/Disc Ratio (Baseline Vist vs Final Visit)
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Mean Value in Nerve Fibers and Ganglion Cell Thickness
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Optic Nerve Image
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit)
Central Corneal Thickness (CCT)
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Visual Fields
Time frame: Days: 0 (basal visit) and 60 (± 2) (final visit)
Change in Ocular Surface Integrity (Chemosis)
Time frame: Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)
Number of Adverse Events
Time frame: Day: 75 (± 3) (safety call)
Changes in Ocular Comfort Index
Time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Change in Ocular Surface Integrity (Conjunctival Hyperemia)
Time frame: Days: 0 (basal visit, BV), 14 (± 2) (first follow-up visit, V1), 30 (± 2) (second follow-up visit, V2) and 60 (± 2) (final visit, FV)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40873654Olvera-Montano O, Mejia-Morales C, Jauregui-Franco RO, Gomez-Mendez SC, Munoz-Villegas P. Maximum Tolerated Medical Therapy for Glaucoma: Fixed-Dose Combinations of Timolol, Dorzolamide, Brimonidine with Latanoprost Versus Timolol, Dorzolamide with Latanoprost. Clin Ophthalmol. 2025 Aug 22;19:2913-2925. doi: 10.2147/OPTH.S540312. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dorzolamide-timolol-brimonidine and latanoprost and Dorzolamide-timolol and latanoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
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 6 inclusion and 22 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intraocular Pressure (IOP) (time frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)). 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 NCT04702789, 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 7 May 2026.