NCT03524157

Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects

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 Ophthalmologically and Clinically Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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: * Systemically and ophthalmologically healthy subjects * Signed informed consent. * Age between 18 to 40 years * Both genders * Blood tests complete, blood count (BHC), three element blood chemistry (QS) and liver function tests, within normal parameters * Visual capacity 20/30 or better Test product, dose and route of administration: \- PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution preservative free. 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. Reference product, dose and route of administration: 1. 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. 2. 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: * Goblet cells density . * Presence of adverse events. * Intraocular pressure. * Visual ability * Laboratory tests * Epithelial defects in cornea and conjunctiva. * Ophthalmological signs: conjunctival hyperemia, chemosis. Secondary outcome variables: * Tear film rupture time * Life signs: heart rate, respiratory frequency systemic blood pressure. * Subsequent segment Primary outcome variables of tolerability: * Burning * Foreign body sensation * Itching * Eye comfort index 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.

Conditions

• Dry Eye Syndromes
• Lubricant Allergy
• Tear Disorder

Interventions

Type	Name	Description
DRUG	PRO-087	The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
DRUG	Systane Ultra	The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
DRUG	Xyel Ofteno	The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.

Timeline

• Start date: 2017-07-17
• Primary completion: 2018-02-12
• Completion: 2018-03-27
• First posted: 2018-05-14
• Last updated: 2019-07-19
• Results posted: 2019-07-19

Locations

1 site across 1 country: Mexico