Clinical trial NCT03524157: Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Lubricant Allergy
Tear Disorder
Keywords: Humylub PF
artificial tears
Ophthalmic lubricant
Chondroitin sulfate
Sodium hyaluronate
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2018-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Goblet Cell Density (GCD)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
Secondary outcomes:
measure: Presence of Adverse Events (AEs)
timeFrame: during the 13 days of evaluation, including the safety call (day 13).
measure: Intraocular Pressure (IOP)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Epithelial Defects (ED)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Breakup Time (BUT)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Conjunctival Hyperemia (CH)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Chemosis
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Ocular Burning (OB)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Foreign Body Sensation (FBS)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
measure: Ocular Pruritus (P)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 10)
Other outcomes:
Locations:
city: Zapopan
country: Mexico
facility: Private Ophthalmological Office
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References:
citation: 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.