Direct Application of Systane Complete to Contact Lenses

NCT03848221 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 000523741
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Dry Eye; Contact Lens Complication

Keywords

Systane Complete; Dry Eye; Contact Lens Discomfort; Artificial Tears; Rewetting Drops

Outcome Measures

Primary Outcomes (1)

• Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks

  The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.

  2 Weeks

Secondary Outcomes (1)

• Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.

  2 Weeks

Study Arms (3)

Systane Complete

EXPERIMENTAL

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

Drug: Systane Complete

Sensitive Eyes Rewetting Drops

ACTIVE COMPARATOR

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

Drug: Sensitive Eyes Rewetting Drops

No Treatment

NO INTERVENTION

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

Interventions

Systane Complete DRUG

Systane Complete is an artificial tear.

Systane Complete

Sensitive Eyes Rewetting Drops DRUG

Sensitive Eyes Rewetting Drops is a rewetting drop.

Sensitive Eyes Rewetting Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily disposable contact lens wearers
• /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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alcon Research: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Lindenhurst Eye Physicians & Surgeons, P.C.

Babylon, New York, 11702, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Andrew Pucker
• Organization: The University of Alabama at Birmingham

apucker@uab.edu

920-579-2900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator will be masked to the subject's treatment. The subjects cannot be fully masked because there is a no treatment control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Investigator Masked, Randomized, Clinical Trial

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: May 28, 2019
• Primary Completion: October 20, 2019
• Study Completion: October 20, 2019
• Last Updated: October 8, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)