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NCT03682809 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

A Phase 4 study of Dry Eye and Contact Lens Discomfort, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 4
Development phase
46
Enrollment target
3
Study locations

NCT03682809 is a Phase 4 study of Dry Eye and Contact Lens Discomfort that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 46 participants, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03682809, a Phase 4 study of Dry Eye and Contact Lens Discomfort, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 4
Development phase
46 participants
Enrollment target
3
Study locations

Study 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.

Interventions

  • DRUG Systane Complete

Study Locations (3)

Alabama

  • University of Alabama at Birmingham - Birmingham

New York

  • Lindenhurst Eye Physicians & Surgeons, P.C. - Babylon

Tennessee

  • Southern College of Optometry - Memphis

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2018-11-19
Est. Completion 2019-03-23
Phase Phase 4

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03682809

The ClinicalTrials.gov registry entry for NCT03682809 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (52% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dry Eye appearing as the primary indexed condition, and to 1 intervention - of which Systane Complete is the first listed.

NCT03682809 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, New York, Tennessee.

Frequently Asked Questions

What is clinical trial NCT03682809 about?

NCT03682809 is a clinical study titled "Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort". 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 usi...

What is the current status of trial NCT03682809?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2018-11-19. Estimated completion is 2019-03-23.

What conditions does trial NCT03682809 study?

This clinical trial studies the following conditions: Dry Eye, Contact Lens Discomfort.

What interventions are being tested in trial NCT03682809?

The interventions under investigation include: Systane Complete (DRUG).

Who is sponsoring clinical trial NCT03682809?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03682809 being conducted?

This trial has 3 study locations across Alabama, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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