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

NCT ID: NCT01657253

Last Updated: 2017-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-04-30

Brief Summary

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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®

Detailed Description

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Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.

A phase III randomized double-blind clinical trial will be conducted 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®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRO-148

PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution

doses: 1 drop in each eye, quarter in day

Group Type EXPERIMENTAL

PRO-148

Intervention Type DRUG

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

Systane®

Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar

doses: 1 drop in each eye, quarter in day

Group Type ACTIVE_COMPARATOR

Systane

Intervention Type DRUG

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

Interventions

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PRO-148

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

Intervention Type DRUG

Systane

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

Intervention Type DRUG

Other Intervention Names

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PRO-148 (xanthan gum and sulphate chondroitin) polyethyleneglycol 400, propyleneglycol, hydroxypropyl guar

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leopoldo M Baiza-Durán, MD

Role: STUDY_DIRECTOR

Laboratorios Sophia S.A de C.V.

Locations

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Consultorio privado

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 27645318 (View on PubMed)

Other Identifiers

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SOPH148-0512/III

Identifier Type: -

Identifier Source: org_study_id