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COMPLETED Phase 4

Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

NCT03682809 · View on ClinicalTrials.gov ↗

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

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03682809

The ClinicalTrials.gov registry entry for NCT03682809 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03682809 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Alabama, New York, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03682809?

The interventions under investigation include: Systane Complete (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03682809?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial