Clinical trial NCT03257813: Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)
Official title: Clinical Study to Evaluate the Non-inferiority of PRO-122 an Ophthlamic Solution Manufactured by Laboratorios Sophia, Previous Treatment With Krytantek Ofteno ®, in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: timolol
dorzolamide
brimonidine
Glaucoma
Ocular hypertension
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 60 subjects with diagnosis of open angle primary glaucoma with mild, moderate or severe damage and / or with intraocular hypertension users of Krytantek Ofteno® at least two previous months and are under control Of the corresponding IOP target.

a study group A or B will be randomly assigned, in group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be evaluated again and switched from therapy to solution PRO-122 which will be used for 30 days until the 60th day, date of the final visit.

In the case of those assigned to group B on day 1, the change to PRO-122 solution will be made for 30 continuous days until the date of revision on day 30, the day on which treatment with Krytantek Ofteno® will be restored to continue until the Day 60 for the final evaluation.

The selected subjects will be observed for 60 days.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* male or female.
* obtained in the external consultation.
* With diagnosis primary of open-angle glaucoma and / or hypertension classified as mild, moderate or severe glaucomatous damage, users of Krytantek Ofteno® at least two months prior to inclusion and under control of the target IOP.
* informed consent.

Exclusion Criteria:

General Criteria

1. Subjects with topical or systemic medication that interferes decisively in the results of the study. (Such as topical immunomodulators, lacrimal point tamponade, corticosteroids, ocular hypotensives other than those listed above, artificial tears with preservative).
2. Subjects (female) with an active sex life who are not using a contraceptive method.
3. Female Subjects in pregnancy or breastfeeding.
4. Female subjects with positive urine pregnancy test.
5. Positive drug addiction (verbal interrogation).
6. Subjects who have participated in any clinical research study in the last 40 days.
7. Legally or mentally disabled subjects to give informed consent for their participation in this study.
8. Subjects who can not comply with the appointments or with all the requirements of the protocol.

Ophthalmologic criteria

1. Subject with only one eye with vision.
2. Subjects with visual capacity 20/200 or worse.
3. Subjects with a narrow-angle history without treatment, with or without total or partial closure of the angle in either eye.
4. Subjects with corneal abnormalities that prevent applanation tonometry.
5. Subjects with ocular surgery or ocular trauma 6 months prior to inclusion.
6. Any ocular laser surgery 3 months prior.
7. Any uncontrolled or progressive retinal disease.
8. Inflammatory diseases of any kind.
9. Contact lens wearers.
10. Subjects with a history of hypersensitivity to any of the ingredients of the research product or its analogues.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Change from Baseline intraocular pressure at day 30 and 60.
Secondary outcomes:
measure: Visual Acuity (VA)
timeFrame: Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Other outcomes:
measure: Adverse Events
timeFrame: 75 days, includes the security call
measure: Conjunctival Hyperemia
timeFrame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
measure: Chemosis
timeFrame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
measure: Eye Burning
timeFrame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
measure: Number of Eyes With Tearing
timeFrame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
measure: Number of Eyes With Foreign Body Sensation
timeFrame: Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Locations:
Study officials:
References:
citation: Gomez-Aguayo F, Paczka JA, Lenero-Cordova R, Jimenez-Roman J, Davila-Villarreal J, Hartleben C, Baiza-Duran L, Olvera-Montano O, Garcia-Velez F, Munoz-Villegas P. A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma. Ophthalmol Ther. 2018 Jun;7(1):145-156. doi: 10.1007/s40123-018-0128-8. Epub 2018 Apr 21.