Clinical trial NCT01541891: Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keywords: PRO-148
Dry eye syndrome
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tear Film Break-up Time (TBUT)
timeFrame: During 60 days
Secondary outcomes:
measure: Presence of Adverse Events
timeFrame: 60 days
Other outcomes:
measure: Evaluation of Visual Acuity
timeFrame: 60 days
Locations:
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
state: Jalisco
Study officials:
affiliation: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
name: José F Alaniz-De La O, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
name: Laura R Saucedo-Rodíguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Department. Laboratorios Sophia SA de CV
name: Leopoldo M Baiza-Durán, MD
role: STUDY_DIRECTOR
References: