Direct Application of Systane Complete to Contact Lenses

NCT ID: NCT03848221

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2019-10-20

Brief Summary

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.

Detailed Description

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.

Conditions

Dry Eye; Contact Lens Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Systane Complete

Subjects in this group will use Systane Complete before, during, and after contact lens use.

Group Type: EXPERIMENTAL

Systane Complete

Intervention Type: DRUG

Systane Complete is an artificial tear.

Sensitive Eyes Rewetting Drops

Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use.

Group Type: ACTIVE_COMPARATOR

Sensitive Eyes Rewetting Drops

Intervention Type: DRUG

Sensitive Eyes Rewetting Drops is a rewetting drop.

No Treatment

Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Systane Complete

Systane Complete is an artificial tear.

Intervention Type: DRUG

Sensitive Eyes Rewetting Drops

Sensitive Eyes Rewetting Drops is a rewetting drop.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Andrew Pucker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

000523741

Identifier Type: -

Identifier Source: org_study_id