Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution
      PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.

      Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by
      Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.

      Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability
      similar to Travatan® in healthy subjects.

      Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with
      randomization.
    

Detailed description: 
      Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria:
      Clinically healthy subjects.

      duration: 10 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) or Fisher's exact. An alpha
      ≤ 0.05 will be considered significant.
    

Intervention name(s): PRO 179; Travatan 0.004 % Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): Generic name: Travoprost
Distinctive denomination: Bristrio® (PRO-179)
Active principles: Travoprost 0.004%.
Pharmaceutical form: Ophthalmic solution
Presentation: multi-dose dropper bottle, 2.5 milliliters.
Prepared by: Sophia Laboratories, S.A. of C.V.
Description of the solution: transparent solution, free of visible particles.
Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.; Generic name: Travoprost
Distinctive denomination: Travatan®
Active ingredients: Travoprost 0.004%
Pharmaceutical form: Ophthalmic solution.
Presentation: multi-dose dropper bottle, 2.5 milliliters.
Prepared by: Alcon Laboratories Inc.
Description of the solution: transparent solution, free of visible particles.
Consult information to prescribe.
Other intervention name(s): PRO-179; Bristrio®; Travoprost 0.004% ophthalmic solution; Travoprost 0.004% ophthalmic solution
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, with randomization.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Travoprost; ophthalmic solution; Prostaglandin Analogues; Antiglaucoma drugs; glaucoma