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Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Full description
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Study period:
3 to 4 months
treatment duration: 10 days
Number of patients:
30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.
Diagnosis and main inclusion criteria:
Test product, dose and route of administration:
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Reference product, dose and route of administration:
Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon Laboratories, Inc.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Evaluation criteria:
Primary security outcome variables:
Secondary outcome variables:
Primary outcome variables of tolerability:
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 through the Kruskal-Wallis test for quantitative variables. The difference between the qualitative variables will be analyzed by means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
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30 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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