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

Laboratorios Sophia

Status and phase: Completed; Phase 1

Conditions: Tear Disorder; Lubricant Allergy; Dry Eye Syndromes

Treatments: Drug: Systane Ultra; Drug: PRO-087; Drug: Xyel Ofteno

Study type: Interventional

Funder types: Industry

Identifiers

NCT03524157

SOPH087-0616/I

Details and patient eligibility

About

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:

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:

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:

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).
• Users of contact lenses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

PRO-087

Experimental group

Description:

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.

Treatment:

Drug: PRO-087

Xyel Ofteno

Active Comparator group

Description:

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.

Treatment:

Drug: Xyel Ofteno

Systane ultra

Active Comparator group

Description:

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.

Treatment:

Drug: Systane Ultra