Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

NCT01657253 | Completed Phase 3 Results DMC

• 1 other identifier: SOPH148-0512/III
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI©) Questionnaire

  Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit.

  Day 60

Secondary Outcomes (2)

• Schirmer Test

  Day 60

• Tear Film Break up Time

  Day 60

Study Arms (2)

PRO-148

EXPERIMENTAL

PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day

Drug: PRO-148

Systane®

ACTIVE COMPARATOR

Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day

Drug: Systane

Interventions

PRO-148 DRUG

Instill 1 drop in each eye four times a day, for 60 days

Also known as: PRO-148 (xanthan gum and sulphate chondroitin)

PRO-148

Systane DRUG

Instill 1 drop in each eye four times a day, for 60 days

Also known as: polyethyleneglycol 400, propyleneglycol, hydroxypropyl guar

Systane®

Eligibility Criteria

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

You may qualify if:

• Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
• OSDI score between 12 and 45
• Provided informed consent

You may not qualify if:

• Patients with one blind eye
• Visual acuity of 20/100 or worst in any eye
• Patients with any active ocular disease that would interfere with study interpretation
• Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
• Patients with history of hypersensitivity or contraindication for any drug used in the study
• Contact lens users
• Pregnant patients, at risk of pregnancy or breastfeeding
• Patients without birth control treatment
• Patients who had participated in any clinical trial in the last 90 days
• Legal or mentally disabled patients who could not give informed consent
• Patients who do not provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Consultorio privado

Guadalajara, Jalisco, 44600, Mexico

Location

Related Publications (1)

• Perez-Balbuena AL, Ochoa-Tabares JC, Belalcazar-Rey S, Urzua-Salinas C, Saucedo-Rodriguez LR, Velasco-Ramos R, Suarez-Sanchez RG, Rodriguez-Carrizalez AD, Oregon-Miranda AA. Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial. BMC Ophthalmol. 2016 Sep 20;16(1):164. doi: 10.1186/s12886-016-0343-9.

  PMID: 27645318 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

xanthan gum; Chondroitin; Propylene Glycol; hydroxypropyl guar

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was performed according to the clinical protocol.

Results Point of Contact

• Title: Leopoldo M Baiza-Duran MD, Director of Clinical Trials
• Organization: Laboratorios Sophia S.A. de C.V.

leopoldo.baiza@sophia.com.mx

52+ 33 30014200

Study Officials

• Leopoldo M 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: August 6, 2012
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)