Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2019-03-23 |
| Phase | Phase 4 |
Interested in This Trial?
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, 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.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
RECRUITING · Phase 4
-
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
RECRUITING · Phase 4
-
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
RECRUITING · Phase 4
-
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
RECRUITING · Phase 4
-
Performance of Systane PRO Versus Refresh Optive Mega-3
RECRUITING · Phase 4
-
A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
ACTIVE NOT RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.