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

Phase 3

Completed

Conditions: Dry Eye

Interventions: Drug: PRO-148
Drug: Systane

Registration Number: NCT01657253

Lead Sponsor: Laboratorios Sophia S.A de C.V.

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®

Detailed 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 183

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO-148	PRO-148	PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day
Systane®	Systane	Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI©) Questionnaire	Day 60	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.

Secondary Outcome Measures

Name	Time	Method
Schirmer Test	Day 60	Change from Baseline in Schirmer test after 60 days of treatment Schirmer test It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit.
Tear Film Break up Time	Day 60	Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal.