Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients W… (NCT01541891) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
Mexico30 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.