Clinical Outcomes of Fixed Versus As-Needed Use ofArtificial Tears in Dry Eye Disease: A 6-Week,Observer-Masked Phase 4 Clinical Trial

Investigative Ophthalmology & Visual Science

article

Penny Asbell¹  Algis J. Vingrys²  Jacqueline Tan³  Abayomi Ogundele⁴  Laura E. Downie²  Gary Jerkins⁵  Lee Shettle⁶ 

[1] Icahn School of Medicine;Department of Optometry and Vision Sciences, University of Melbourne;University of New South Wales;Novartis Pharmaceutical Corporation;Nashville Vision Associates;Shettle Eye Research

关键词: artificial tears;    dry eye disease;    ocular surface staining;    symptom bother;    dosageregimen;   

DOI  :  10.1167/iovs.17-23733

学科分类：社会科学、人文和艺术（综合）

来源: Association for Research in Vision and Ophthalmology

【 摘 要 】

PURPOSE. To evaluate the clinical effects of using fixed (four times daily [QID]) versus asneeded (PRN) dosing of an artificial tear product (polyethylene glycol/propylene glycol [PEG/PG]; Systane Ultra) in individuals with dry eye disease.METHODS. In this prospective, multicenter, observer-masked, active-control, parallel-grouptrial, participants were randomized (1:2 allocation) to receive 1 drop of PEG/PG QID (n ¼ 34)or PRN (n ¼ 63) for 28 days. The primary endpoint was change from baseline in the totalocular surface staining (TOSS) score (according to the Oxford scale) at day 28.RESULTS. At day 28, the change from baseline in least squares mean (LSM) TOSS scores for QIDand PRN groups were 1.19 and 0.94, respectively (treatment difference [TD]: 0.26; 95%confidence interval [CI]: ‘ to 0.21; P ¼ 0.184); superiority of QID versus PRN dosing wasnot established, as the upper limit of one-sided 95% CI for TD was not <0 (prespecified limit).At day 28, for QID and PRN groups, the LSM change from baseline in Impact of Dry Eye onEveryday Life (IDEEL) scores was symptom-bother, 7.0 and 2.94 (TD: 4.06, P ¼ 0.037);treatment effectiveness, 2.43 and 0.16 (TD: 2.28, P ¼ 0.278); and treatment-relatedinconvenience, 11.56 and 2.77 (TD: 8.8, P ¼ 0.996), respectively. Incidence of adverseevents was low (3.2%) in both the groups; no serious adverse events were reported.CONCLUSIONS. QID dosing of PEG/PG was not superior to PRN dosing in terms of ocularstaining. The IDEEL symptom-bother score favored QID dosing, suggesting that regular use ofartificial tears may provide better symptomatic relief than PRN use. (ClinicalTrials.govnumber, NCT02446015.).

【 授权许可】

CC BY|CC BY-NC-ND