Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Completed · Phase 4

Conditions studied: Contact Lens Discomfort, Dry Eye

In brief

Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.

Key facts

Study ID

NCT03682809

Run by

University of Alabama at Birmingham

People needed

46

Starts

2018-11-19

Expected to finish

2019-03-23

Last updated by the study team

2020-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Self-reported contact lens discomfort
• Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
• Daily disposable contact lens wearer
• Best-corrected visual acuity of 20/30 or better

You may not qualify if…

• All other contact lens types (e.g., currently wearing two week or monthly replacement contact lenses or hard contact lenses)
• Non-compliant daily disposable contact lens wearers (must regularly replace contact lenses daily)
• Systemic health conditions known to alter tear film physiology
• History of ocular surgery within the past 12 months
• History of severe ocular trauma, active ocular infection, or inflammation
• Currently using Accutane or eye medications
• Pregnant or breast feeding

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Lindenhurst Eye Physicians & Surgeons, P.C. — Babylon, New York, United States
• Southern College of Optometry — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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