CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Systane Completedrug
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/NCT03682809
NCT03682809Phase 4Completed

Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

University of Alabama at Birmingham·interventional·Posted Sep 25, 2018·Updated Apr 6, 2020

In Brief

A Phase 4 clinical trial evaluating Systane Complete for Contact Lens Discomfort and Dry Eye. Completed, enrolled 46 participants across 3 sites.

Detailed Summary

Clinicians commonly use artificial tears off label for treating contact lens (CL) discomfort and the dry eye associated with CLs because new artificial tear formulations have the potential to outperform the available CL rewetting drops. While off-label, McDonald et al. have previously shown that using a common artificial tear, Systane Ultra, before and after CL use is an effective means for treating daily disposable CL wears who have CL discomfort. Recently, a new formulation of artificial tears, Systane Complete, was released to the market. Systane Complete is a unique formulation that has combined elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (indicated for evaporative dry eye) to create an artificial tear with an indication for aqueous deficient, evaporative, and mixed (both aqueous deficient and evaporative) dry eye. Thus, the goal of this study is to determine in a randomized clinical trial if Systane Complete is able to effectively improve the symptoms of patients who have CL discomfort.

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 25, 2018
Enrollment StartNov 19, 2018
Primary CompletionMar 23, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.8 years ago

Interventions

Systane Completedrug

Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.