Direct Application of Systane Complete to Contact Lenses

Soft contact lenses are the ideal vision correction choice for many patients because soft
contact lenses allow patients to have better and less restricted vision, they allow for an
increased ability to perform work tasks and play sports, and they provide patients with a
better perceived cosmetic appearance compared to spectacle lenses. While millions of people
worldwide benefit from contact lenses, many of these patients experience contact lens
discomfort, which limits their wear time and in many instances eventually result in
discontinuation of contact lens use. In fact, 21% to 64% of contact lens wearers permanently
discontinue contact lens use because of ocular discomfort. Contact lens discomfort is
currently defined as "a condition characterized by episodic or persistent adverse ocular
sensations related to lens wear, either with or without visual disturbance, resulting from
reduced compatibility between the contact lens and the ocular environment, which can lead to
decreased wearing time and discontinuation of contact lens wear." Although contact lens
discomfort may stem from the lens itself, a situation that can be corrected by such means as
switching to an alternative material or wear schedule, contact lens discomfort more typically
occurs from ocular surface disease.

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 lens use.
While rewetting drops and artificial tears are regulated under different U.S. Food & Drug
Administration policies, artificial tears are not specifically indicated for 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 (e.g., some artificial tears have lipid supplements that have the
potential to restore the external tear lipid layer). The safe and effective use of artificial
tears with contact lenses is supported by Caffery and Josephson and Ozkan and Papas who found
that artificial tears significantly reduce dryness symptoms in contact lens wearers. However,
the community currently lacks a rigorous scientific study aimed at understanding the utility
of lipid-containing artificial tear (or rewetting drop) for alleviating contact lens
discomfort while patients are wearing their contact lenses. Systane Complete, a new
formulation of artificial tears, combines elements from both Systane Ultra (indicated for
aqueous deficient dry eye) and Systane Balance (lipid-containing artificial tear indicated
for evaporative dry eye). Thus, the purpose of this study is to test the safety of Systane
Complete and its ability to alleviate contact lens discomfort during the day while subjects
are wearing their contact lenses. This goal will be accomplished by randomizing subjects to
either Systane Complete, a commercially available rewetting drop, or no treatment.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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