Phase 2
N=30
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01541891 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Tear Film Break-up Time (TBUT) — 5.2; 4.7; 6.1; 7.3 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRO-148 Ophthalmic Solution (Drug); Active Comparator: SYSTANE ® Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Break-up Time (TBUT) |
5.2; 4.7; 6.1; 7.3 | — |
| SECONDARY Presence of Adverse Events |
1; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01541891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.