Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

Summary

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Timeline

Start

2015-06-19

Primary completion

2016-06-21

Completion

2016-06-21

Outcome

Missed primary endpoint

paper superiority of QID versus PRN dosing was not established, as the upper limit of one-sided 95% CI for TD was not <0 PMID 29715369 ↗

Publications

• Asbell P, Vingrys AJ, Tan J, Ogundele A, Downie LE, Jerkins G, Shettle L. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2275-2280. doi: 10.1167/iovs.17-23733.

Drugs

Indications