Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Number of patients: n = 24 12 subjects per group (both eyes). Main inclusion criteria:
      Clinically healthy subjects.

      Treatment duration: 7 days. Duration of subject in the study: 15 to 22 days.

      Adverse events will be reported and cataloged based on the MedDRA dictionary and will be
      reported to the corresponding regulatory entity.

      The sponsor will carry out monitoring or quality visits to the research sites where it
      corroborates the information of the source documents and will contrast them with the
      information presented in the electronic CRF. Electronic case report forms will be evaluated
      by the clinical research associate and the clinical team of the sponsor (medical
      ophthalmologist researcher and pharmacologist of clinical safety).

      Statistical methodology:

      The data will be expressed with measures of central tendency: mean and standard deviation for
      the quantitative variables. The qualitative variables will be presented in frequencies and
      percentages. The statistical analysis will be carried out by means of the Mann-Whitney U test
      for the quantitative variables for the difference between the groups. The difference between
      the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be
      considered significant.
    

Intervention name(s): PRO-122; Krytantek Ofteno®
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): timolol 0.5%; brimonidine 0.2%; dorzolamide 2%; Krytantek PF; Krytantek Ofteno® Preservative Free; timolol 0.5%; brimonidine 0.2%; dorzolamide 2%
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glaucoma; Krytantek; Krytantek PF; PRO-122