N/A N=91 Randomized Single-blind Treatment

Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

Dry Eye Syndrome · Lipid Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT01688726 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Nov 2014

Primary outcome: Primary: Mean Bulbar Conjunctival Staining — 0.743; 0.442; 0.531; 0.443 percentage of staining

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SYSTANE® BALANCE eyedrops (Other); Minims® Saline 0.9% eyedrops (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Bulbar Conjunctival Staining	0.743; 0.442; 0.531; 0.443	—
SECONDARY High Contrast logMAR Time Controlled Visual Acuity (TCVA)	0.220; 0.253; 0.206; 0.295; 0.240; 0.202	—
SECONDARY Non Invasive Tear Film Break-up-time (NIBUT)	9.39; 7.47; 9.53; 7.66; 7.81; 8.74	—

Summary

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Eligibility Criteria

Inclusion Criteria

Non-contact lens wearer;
Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
Lipid deficiency;
Best visual acuity of 6/9 or better in each eye;
Willingness to adhere to the instructions set in the clinical protocol;
Signature of the subject informed consent form;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Use of systemic medication which might produce dry eye side effects;
Systemic disease which might produce dry eye side effects;
Active or recent ocular inflammation or infection;
Use of ocular medication;
Significant ocular anomaly;
Previous ocular surgery;
Previous use of Restasis;
Any medical condition that might be prejudicial to the study;
Pregnant or lactating;
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01688726). 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.