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

Laboratorios Sophia

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Drug: Systane; Drug: PRO-148

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657253

SOPH148-0512/III

Details and patient eligibility

About

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®

Full description

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

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups

PRO-148

Experimental group

Description:

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

Treatment:

Drug: PRO-148

Systane®

Active Comparator group

Description:

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

Treatment:

Drug: Systane