Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PRO-122; Krytantek Ofteno®
Intervention description: 1 drop every 12 hours for 30 days of alternating treatment with 30 days; 1 drop every 12 hours for 30 days of alternating treatment with 30 days
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
Masking description: Masking will be carried out using identical boxes in the primary package in both groups.
Blinding for the research subject and the investigator will be carried out by using labels containing the assignation number, which will replace the original labels in the case of the comparator. Due to the nature of the primary containers of the research products, single-dose vials and multidose bottle, it is not possible to use identical labels.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: timolol; dorzolamide; brimonidine; Glaucoma; Ocular hypertension

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
    

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.