CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 73 enrolled
Drug / intervention
Systane Complete +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03848221
NCT03848221Phase 4Completed

Direct Application of Systane Complete to Contact Lenses for the Treatment of Contact Lens Discomfort

University of Alabama at Birmingham·interventional·Posted Feb 20, 2019·Updated Oct 8, 2020

In Brief

A Phase 4 clinical trial evaluating Systane Complete and Sensitive Eyes Rewetting Drops for Dry Eye and Contact Lens Complication. Completed, enrolled 73 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAlcon Research

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 20, 2019
Enrollment StartMay 28, 2019
Primary CompletionOct 20, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.4 years ago

Interventions

Systane Completedrug

Systane Complete is an artificial tear.

Sensitive Eyes Rewetting Dropsdrug

Sensitive Eyes Rewetting Drops is a rewetting drop.