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
Overview
- Phase
- Phase 1
- Intervention
- PRO-087
- Conditions
- Dry Eye Syndromes
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Goblet Cell Density (GCD)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Systemically and ophthalmologically healthy subjects
- •Signed informed consent.
- •Age between 18 to 40 years.
- •Both genders
- •Blood tests \[complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)\] within normal parameters
- •Visual capacity 20/30 or better
Exclusion Criteria
- •Subjects with a history of hypersensitivity to any of the components of the research products.
- •Subject users of topical ophthalmic medications of any pharmacological group.
- •Subject users of medication by any other route of administration.
- •Women who are pregnant or breastfeeding.
- •Women without a history of hysterectomy, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- •Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- •Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- •Inability to attend or answer the evaluations made in each of the visits.
- •Positive smoking (specified as cigarette consumption regardless of quantity and frequency)
- •Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
Arms & Interventions
PRO-087
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Intervention: PRO-087
Xyel Ofteno
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle.
Intervention: Xyel Ofteno
Systane ultra
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc.
Intervention: Systane Ultra
Outcomes
Primary Outcomes
Goblet Cell Density (GCD)
Time Frame: will be evaluated at the end of the treatment at the final visit (day 10)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
Secondary Outcomes
- Conjunctival Hyperemia (CH)(will be evaluated at the end of the treatment at the final visit (day 10))
- Presence of Adverse Events (AEs)(during the 13 days of evaluation, including the safety call (day 13).)
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 10))
- Epithelial Defects (ED)(will be evaluated at the end of the treatment at the final visit (day 10))
- Breakup Time (BUT)(will be evaluated at the end of the treatment at the final visit (day 10))
- Chemosis(will be evaluated at the end of the treatment at the final visit (day 10))
- Ocular Burning (OB)(will be evaluated at the end of the treatment at the final visit (day 10))
- Foreign Body Sensation (FBS)(will be evaluated at the end of the treatment at the final visit (day 10))
- Ocular Pruritus (P)(will be evaluated at the end of the treatment at the final visit (day 10))