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

NCT ID: NCT03524157

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2018-03-27

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.

Conditions

Dry Eye Syndromes; Lubricant Allergy; Tear Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

PRO-087

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Xyel Ofteno

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Systane Ultra

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

chondroitin sulfate + sodium hyaluronate; Humylub PF; humylub preservative-free ophthalmic solution; humylub preservative-free ophthalmic solution PF; humylub preservative-free; humylub PF preservative-free; humylub PF ophthalmic solution; Polyethylene glycol 400 0.4%, propyleneglycol 0.3%; Xanthan gum 0.9 mg, sodium chondroitin sulfate

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).
• Users of contact lenses.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo Baiza Durán, MD

Role: STUDY_DIRECTOR

Laboratorios Sophia S.A de C.V.

Locations

Private Ophthalmological Office

Zapopan, Jalisco, Mexico

Countries

Mexico

References

Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.

Reference Type: DERIVED

PMID: 34707360 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOPH087-0616/I

Identifier Type: -

Identifier Source: org_study_id