Direct Application of Systane Complete to Contact Lenses

Completed · Phase 4

Conditions studied: Dry Eye, Contact Lens Complication

In brief

A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.

Key facts

Study ID

NCT03848221

Run by

University of Alabama at Birmingham

People needed

73

Starts

2019-05-28

Expected to finish

2019-10-20

Last updated by the study team

2020-10-08

Who can join

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

You may qualify if…

• Daily disposable contact lens wearers
• 20/30 visual acuity or better
• Self-report contact lens discomfort
• Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12

You may not qualify if…

• Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
• Non-compliant daily disposable contact lens wearers
• Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
• History of ocular surgery within the past 12 months
• History of severe ocular trauma
• History of active ocular infection or inflammation
• Isotretinoin-derivatives use
• Ocular medication use
• 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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