N/A
Completed N=231
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
Source: ClinicalTrials.gov NCT02776670 ↗Enrolled (actual)
231
Serious AEs
0.4%
Results posted
Jun 2019
Primary outcomePrimary: Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35 — 0.999; 0.864 seconds — p=<0.0001
Summary
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35 |
0.999; 0.864 | <0.0001 sig |
| SECONDARY Change From Baseline in TFBUT at Day 35 |
0.985; 0.867 | 0.310 |
| SECONDARY Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35 |
— | — |
| SECONDARY Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35 |
-9.9; -8.8 | 0.618 |
Eligibility Criteria
Inclusion Criteria
- Willing and able to attend all study visits;
- Must sign an informed consent form;
- Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
- Willing to take study products as directed for entire study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
- Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
- Use of medication excluded by the protocol;
- Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- Ocular surgeries or procedures excluded by the protocol;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02776670). 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. Informational only — not medical advice.