Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: PRO 179; Travatan 0.004 % Ophthalmic Solution
Intervention description: 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.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, with randomization.
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 teams blinded / not blinded.
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.
Legend "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: Travoprost; ophthalmic solution; Prostaglandin Analogues; Antiglaucoma drugs; glaucoma

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be clinically healthy.

          -  Have the ability to give their signed informed consent and show willingness to comply
             with the study procedures

          -  Have an age between 18 to 45 years.

          -  Indistinct sex.

          -  Women should ensure the continued use of a hormonal contraceptive method or
             intrauterine device (IUD) during the study period.

          -  Present 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.

               -  Present visual ability 20/30 or better in both eyes.

               -  Present vital signs within normal parameters.

               -  Present intraocular pressure ≥10 and ≤ 21 mmHg.

        Exclusion Criteria:

          -  Be a user of topical ophthalmic products of any kind.

          -  Be a user of medicines, or herbal products, by any other route of administration, with
             the exception of hormonal contraceptives in the case of women.

          -  In case of being a woman, being pregnant or breastfeeding.

          -  Have participated in clinical research studies 90 days prior to inclusion in the
             present study.

          -  Have previously participated in this same study.

          -  Be a user of contact lenses and can not suspend their use during the study.

          -  That they can not follow the lifestyle considerations described in section 6.2.2

          -  Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion
             in the present study.

          -  Having a history of any chronic-degenerative disease.

          -  Present inflammatory or infectious disease, active at the time of admission to the
             study.

          -  Present injuries or unresolved traumas at the time of entering the study.

          -  Having the antecedent of any type of eye surgery.

          -  Having undergone surgical procedures, not ophthalmological, in the last 3 months.