A Phase 3 interventional study of PRO-122 and Krytantek Ofteno® in Primary Open Angle Glaucoma and Ocular Hypertension, sponsored by Laboratorios Sophia S.A de C.V.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 3, Interventional, and Treatment
Aim: To demonstrate the non-inferiority of the PRO-122 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus Krytantek Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.
Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 30 patients will be assigned to receive the ophthalmic solution: Krytantek Ofteno ® (timolol 0.5%%/brimonidine 0.2%/dorzolamide 2%) 1 drop B.I.D. during 30 days and the second sequence 30 patients will be assigned to receive the ophthalmic solution: PRO-122 1 drop B.I.D. during 30 days in the same period. Washout period: 20 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days
The American Academy of Ophthalmology Glaucoma Panel: The primary open angle glaucoma (POAG) is a progressive, chronic optic neuropathy in adults in which intraocular pressure (IOP) and other currently unknown factors contribute to damage and in which, in the absence of other identifiable causes, there is a characteristic acquired atrophy of the optic nerve and loss of retinal ganglion cells and their axons. This condition is associated with an anterior chamber angle that is open by gonioscopic appearance.
This is a multicentric, crossover, double blind and prospective clinical study. The investigators will include patients with confirmed diagnosis of primary open-angle glaucoma or ocular hypertension, with target intraocular pressure (TIOP) within a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.
Patients will be randomly divided into 2 groups, one of them treated with a known formulation of timolol 0.5%/brimonidine 0.2%/dorzolamide 2% (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with PRO-122 ophthalmic solution. Patients will receive 1 drop B.I.D. into the lower conjunctival sac of either formulations and were examined at days: 1, 15, 30, 45 and 61 after initiation of treatment. A phone call security at day 75 will be performed.
Primary efficacy outcome: To evaluate the efficacy of PRO-122 versus Krytantek Ofteno® instilled onto the ocular surface in subjects with primary open angle glaucoma (POAG) or ocular hypertension (HTO), to control and maintenance of the target intraocular pressure (TIOP).
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
General Criteria
Ophthalmologic criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be retested and switched to a PRO-122 solution which will be used for 30 days until the 60th day, The final visit.
Drug: PRO-122 · Drug: Krytantek Ofteno®
In group B, therapy with Krytantek Ofteno® will be suspended and changes for PRO-122 for 30 days, in which the subject will be retested and later switched to Krytantek Ofteno® solution which will be used for 30 days until the 60th day, The final visit.
Drug: PRO-122 · Drug: Krytantek Ofteno®
1 drop every 12 hours for 30 days of alternating treatment with 30 days
Also known as: timolol, dorzolamide, brimonidine
1 drop every 12 hours for 30 days of alternating treatment with 30 days
Also known as: timolol, dorzolamide, brimonidine
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. The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60).
Time frame: Change from Baseline intraocular pressure at day 30 and 60.
Visual Acuity (VA)
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated.
Time frame: Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Adverse Events
The presence of adverse events by percentage between groups will be evaluated. the scale is present or absent.
Time frame: 75 days, includes the security call
Conjunctival Hyperemia
the conjunctival hyperemia will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
Time frame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Chemosis
Chemosis: qualitative ordinal variable, will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
Time frame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Eye Burning
Eye ocular burning will be evaluated by the presence or absence of it and the number of affected by group will be reported.
Time frame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Number of Eyes With Tearing
Tearing will be evaluated by the presence or absence of it and the number of affected by group will be reported
Time frame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Number of Eyes With Foreign Body Sensation
Foreign body sensation will be evaluated by the presence or absence of it and the number of affected by group will be reported.
Time frame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
| Milestone | Group A | Group B |
|---|---|---|
| Started | 30 | 30 |
| Completed | 24 | 27 |
| Not completed | 6 | 3 |
| Withdrew: Protocol violation | 6 | 3 |
Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg. The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60).
| mmHg | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 13.60 ± 2.9 | 12.13 ± 1.8 |
| Crossover visit (day 30) | 13.19 ± 3.2 | 11.80 ± 2.1 |
| Final visit (day 60) | 12.60 ± 3.0 | 11.24 ± 1.6 |
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated.
| score on a scale | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 38.31 ± 3.577 | 39.48 ± 3.742 |
| Crossover visit (day 30) | 36.85 ± 3.806 | 40.43 ± 3.753 |
| Final visit (day 60) | 38.98 ± 3.717 | 35.50 ± 3.402 |
The presence of adverse events by percentage between groups will be evaluated. the scale is present or absent.
| percentage of adverse events | PRO-122 | Krytantek Ofteno |
|---|---|---|
| mild | 55.6 | 18.2 |
| moderate | 44.4 | 72.7 |
| severe | 0 | 9.1 |
the conjunctival hyperemia will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
| percentage of eyes | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 39.6 | 11.1 |
| Crossover visit (day 30) | 37.5 | 25.9 |
| Final visit (day 60) | 20.8 | 13.0 |
Chemosis: qualitative ordinal variable, will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
| percentage of chemosis | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 0 | 3.7 |
| Crossover visit (day 30) | 0 | 3.7 |
| Final visit (day 60) | 0 | 0 |
Eye ocular burning will be evaluated by the presence or absence of it and the number of affected by group will be reported.
| number of eye burning | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 16 | 18 |
| Crossover visit (day 30) | 12 | 18 |
| Final visit (day 60) | 14 | 19 |
Tearing will be evaluated by the presence or absence of it and the number of affected by group will be reported
| eyes | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 9 | 2 |
| Crossover visit (day 30) | 8 | 9 |
| Final visit (day 60) | 7 | 9 |
Foreign body sensation will be evaluated by the presence or absence of it and the number of affected by group will be reported.
| eyes | Sequence A | Sequence B |
|---|---|---|
| basal visit (day 1) | 14 | 14 |
| Crossover visit (day 30) | 14 | 16 |
| Final visit (day 60) | 5 | 7 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-122 | 0/60 (0%) | 0/60 (0%) | 12/60 (20%) |
| Krytantek Ofteno® | 0/60 (0%) | 1/60 (1.7%) | 8/60 (13.3%) |
| Event | PRO-122 | Krytantek Ofteno® |
|---|---|---|
| acute gastritisGastrointestinal disorders | 0/60 | 1/60 |
| Event | PRO-122 | Krytantek Ofteno® |
|---|---|---|
| rhinopharyngitisRespiratory, thoracic and mediastinal disorders | 4/60 | 1/60 |
| Dotted KeratopathyEye disorders | 0/60 | 3/60 |
| headacheGeneral disorders | 2/60 | 0/60 |
| allergic BlepharokeratoconjunctivitisEye disorders | 2/60 | 0/60 |
| pharyngitis tonsillitisGastrointestinal disorders | 2/60 | 1/60 |
| Meniere syndrome exacerbatedGeneral disorders | 1/60 | 0/60 |
| vertigoEar and labyrinth disorders | 1/60 | 0/60 |
| atopic dermatitisSkin and subcutaneous tissue disorders | 0/60 | 1/60 |
| maxillary traumatismMusculoskeletal and connective tissue disorders | 1/60 | 0/60 |
| bacterial conjunctivitisEye disorders | 1/60 | 1/60 |
| Age, Continuous(years) | Group A | Group B | Total |
|---|---|---|---|
| Mean | 68.43 ± 8.86 | 64.37 ± 12.84 | 66.44 ± 11.17 |
| Sex: Female, Male(Participants) | Group A | Group B | Total |
|---|---|---|---|
| Female | 24 | 21 | 45 |
| Male | 6 | 9 | 15 |
| Race/Ethnicity, Customized(Participants) | Group A | Group B | Total |
|---|---|---|---|
| hispanic | 30 | 30 | 60 |
No study locations are listed for this record.
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Studies of the drug tested here: PRO-122
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