Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)

NCT03223909 | Completed Phase 4 Results DMC

• 1 other identifier: SOPH087-0415/IV
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ® Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.). Controlled, randomized, double-blind, masked clinical study, comparing the safety and efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a period of 90 days plus 15 days of remote surveillance, in which one of the three agents will be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d. dosage. in both eyes, with regular follow-up visits (5 overall). Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor requiring different treatments of any of the three interventions in this study They will be randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will be administered.

Conditions

Dry Eye Syndrome

Keywords

dry eye; Chondroitin sulfate; Ocular lubricants

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Best-corrected visual acuity

  Change from Baseline visual acuity at 90 days

Secondary Outcomes (7)

• Corneal Epithelization Defects With Rose of Bengal

  Final Visit (day 90)

• Tear Film Break-up Time (TBUT)

  Base line and Final Visit (day 90)

• Schirmer Test

  Base line and Final Visit (day 90)

• Adverse Events

  90 days

• Ocular Surface Disease Index (OSDI)

  Change from Baseline OSDI at 90 days

Study Arms (3)

PRO-087 PF

EXPERIMENTAL

Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.

Drug: PRO-087

Systane Ultra

ACTIVE COMPARATOR

Systane Ultra ophthalmic solution, Dropper bottle, Multidose. 1 drop every 4 hours for 90 days.

Drug: Systane Ultra

Systane Ultra PF

ACTIVE COMPARATOR

Systane Ultra, preservative free ophthalmic solution, single-use vials. 1 drop every 4 hours for 90 days.

Drug: Systane Ultra Preservative Free

Interventions

PRO-087 DRUG

0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate

Also known as: Chondroitin sulfate, sodium hyaluronate

PRO-087 PF

Systane Ultra DRUG

Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative.

Also known as: polyethylene glycol 400, propylene glycol

Systane Ultra

Systane Ultra Preservative Free DRUG

Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,

Also known as: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%

Systane Ultra PF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 to \< 90 years old
• Both sexes
• Mild to moderate tear film dysfunction clinical diagnose
• Mild to moderate clinical stage of the disease
• TBUT \> 5 sec. and \< 10 sec.
• Schirmer: \> 4 mm and \< 14 mm
• OSDI \< 30 points
• Corneal staining \< grade III on the Oxford scale
• Availability to go to each revision when indicated.

You may not qualify if:

• General Criteria
• Subjects with topical and/or systemic medication or mechanical devices that interfere determinedly on the results of the study (such as topical immunomodulators, punctal plugs, corticosteroids, preservative artificial tears, contact lenses).
• Subjects (females) with active sexual life that do not use a contraceptive method.
• Female subjects who are pregnant or lactating
• Female subjects with a positive urine pregnancy test
• Positive drug addictions\* (verbal interrogatory)
• Subjects who have participated on any other research clinical trials on the last 40 days
• Subjects legal or mentally disabled to give an informed consent for participating on this study
• Subjects who can't comply with the appointments or with every protocol requirement.
• Criteria related with ophthalmic ailments
• Serious tear film dysfunction syndrome TBUT \< 5 s Schirmer: \< 4 mm OSDI \> 30 pints Corneal staining \> grade III on the Oxford scale
• Non perforated corneal ulcer
• Perforated corneal ulcer
• Autoimmune corneal ulcer
• Ocular surface scarring diseases

Sponsors & Collaborators

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

Study Sites (1)

Fernando Rodriguez Sixtos Higuera

Irapuato, Guanajuato, 36670, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Chondroitin Sulfates; Hyaluronic Acid; polyethylene glycol 400; Propylene Glycol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Chondroitin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist)
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza, 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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The double-blind study is a procedure in which the patient and the treating doctor ignore to which intervention group the study patient was assigned. To achieve the blinding of both the drug in research and both comparator drugs, these will be labeled in the same way (masking). Besides the figure of an unblinded pharmacist, who is responsible for the delivery of the medication to the patient, will be added. Blinding codes are protected by an outsider appointed by the study sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the investigator in case a subject presents a serious adverse event, prior authorization from the study sponsor; the blinding also continues rigorous during the data analysis and interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 21, 2017
• Study Start: October 13, 2016
• Primary Completion: October 16, 2018
• Study Completion: December 16, 2018
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)