Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

— PRO-148  

Official title:

Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541891
• Other study ID #: COXAVSSY0311FII
• Secondary ID: PRO-148
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2018
• Source: Laboratorios Sophia S.A de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Description:

A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of mild-to-moderate drye eye syndrome.

• Male or female patients.

• Patients 18 years of age

Exclusion Criteria:

• Patients with one blind eye.

• Visual acuity of 20/40 in any eye

• Patients with history of active stage of any other concomitant ocular disease.

• Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.

• Contraindications or sensitivity to any component of the study treatments.

• Ocular surgery within the past 3 months.

• Contact lens users.

• Females of childbearing potential )may not participate in the study if any of the following conditions exist:

• They are pregnant,

• They are breastfeeding,

• They have a positive urine pregnancy test at screening,

• They intend to become pregnant during the study, or

• They do not agree to use adequate birth control methods for the duration of the study.

• Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Discontinuation criteria:

• Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• PRO-148 Ophthalmic Solution
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
• Active Comparator: SYSTANE ® Ophthalmic Solution
Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.

Locations

Country	Name	City	State
Mexico	Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco

Sponsors (1)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of Visual Acuity	The LogMAR scale evaluates the visual acuity of subjects with a logarithmic scale where base 0 is the best visual acuity and 1 is the worst. This variable will be reported with means for comparison between groups.	60 days
Primary	Tear Film Break-up Time (TBUT)	TBUT was evaluated at baseline and end of the study	During 60 days
Secondary	Presence of Adverse Events	The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.	60 days