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:

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.

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