Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: PRO-122; Krytantek Ofteno®
Intervention description: PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
Route of administration: topical ophthalmic.; - 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
- Route of administration: topical ophthalmic.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Masking: Double (Investigator, Outcomes Assessor)
Masking description: Blinding will correspond to the principal investigator and coinvestigator. In addition, the statistical analysis will be carried out in a blinded manner for the final analysis. Blinding can not be guaranteed in the subject.
The masking will be done through the secondary container. The primary packaging will not be masked by the morphological difference between them. The sponsor and the research center will have two blind / non-blind teams.
They will be identified by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least:
Name, address and telephone number of the sponsor.
Pharmaceutical form and route of administration.
Lot Number.
Caption "Exclusively for clinical studies"
Date of Expiry
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glaucoma; Krytantek; Krytantek PF; PRO-122

Summary:

      Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular
      hypertension.

      Objectives: To evaluate the safety and tolerability of the preservative-free formulation
      PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically
      healthy subjects.

      Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability
      similar to Krytantek Ofteno®, in healthy subjects.

      Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.

      Number of patients: n=24 12 subjects per group (both eyes). Main inclusion
      criteria:Clinically healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Clinically healthy

          -  Ability to give your signed informed consent, and show willingness to comply with
             study procedures and to modify your lifestyle activities (Section 6.2.2)

          -  Age between 18 to 45 years.

          -  Indistinct sex.

          -  Women must ensure a hormonal contraceptive method or intrauterine device during the
             study period.

          -  Blood tests: within normal parameters or with a range of ± 20% as long as the subject
             is clinically healthy.

               -  Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes,
                  platelets, mean corpuscular volume and mean corpuscular hemoglobin.

               -  Blood chemistry of three elements (QS): Glucose, urea and creatinine.

               -  Liver function tests (PFH): Aspartate Aminotransferase and Alanine
                  Aminotransferase, total bilirubin, direct and indirect.

          -  Visual ability 20/30 or better in both eyes.

          -  Vital signs within normal parameters.

          -  Intraocular pressure ≥10 and ≤ 21 mmHg.

        Exclusion Criteria:

          -  Users of topical ophthalmic products of any kind.

          -  Users of medicines, or herbal products, by any other route of administration, with the
             exception of hormonal contraceptives in the case of women.

          -  Women who are pregnant or breastfeeding.

          -  Participation in clinical research studies 90 days prior to inclusion in the present
             study.

          -  Previous participation in this same study.

          -  Users of contact lenses.

          -  History of any chronic-degenerative disease.

          -  Inflammatory or infectious disease, active at the time of study entry.

          -  Injuries or traumatisms not resolved at the time of admission to the study.