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

NCT03524157 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH087-0616/I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Lubricant Allergy; Tear Disorder

Keywords

Humylub PF; artificial tears; Ophthalmic lubricant; Chondroitin sulfate; Sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• Goblet Cell Density (GCD)

  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

  will be evaluated at the end of the treatment at the final visit (day 10)

Secondary Outcomes (9)

• 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)

• Conjunctival Hyperemia (CH)

  will be evaluated at the end of the treatment at the final visit (day 10)

Study Arms (3)

PRO-087

EXPERIMENTAL

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.

Drug: PRO-087

Xyel Ofteno

ACTIVE COMPARATOR

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.

Drug: Xyel Ofteno

Systane ultra

ACTIVE COMPARATOR

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.

Drug: Systane Ultra

Interventions

PRO-087 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.

Also known as: 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

PRO-087

Systane Ultra 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.

Also known as: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%

Systane ultra

Xyel Ofteno 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.

Also known as: Xanthan gum 0.9 mg, sodium chondroitin sulfate

Xyel Ofteno

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

Private Ophthalmological Office

Zapopan, Jalisco, 45050, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34707360 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

chondroitin sulfate, sodium hyaluronate drug combination; polyethylene glycol 400; xanthan gum; Chondroitin Sulfates

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: PhD. Ricardo Llamas
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding It will consist in the elimination of the primary label (commercial) in the case of Xyel Ofteno® and Systane Ultra® and the placement of a label identical to the other interventions. Because the bottle in which Systane Ultra® is packaged differs in the color and shape of the lid used by Xyel Ofteno® and PRO-087, a masking will be carried out on the primary packaging which will be identical for the three interventions.The allocation sequence will be generated by personnel assigned. The research center will receive a set of envelopes which will contain the intervention number individually. The envelopes will be identical on the outside. Each of these envelopes will be shown to the participants for their election by the principal investigator or by a designated member of their team. The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the all analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 14, 2018
• Study Start: July 17, 2017
• Primary Completion: February 12, 2018
• Study Completion: March 27, 2018
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)