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Artificial Tears

Systane Complete for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 2 weeks
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Dry Eye Syndrome
  • Contact Lens Discomfort

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Contact Lens Symptoms
Secondary study objectives
Corneal Staining
End of Day Eye Comfort
Schirmer's I Test Without Anesthetic
+1 more

Side effects data

From 2020 Phase 4 trial • 21 Patients • NCT04091581
10%
Common cold
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-Dry Eye
Dry Eye

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Systane CompleteExperimental Treatment1 Intervention
Subjects randomized to this group will be asked to use Systane Complete once before and after contact lens use.
Group II: No TreatmentActive Control1 Intervention
Subjects randomized to this group will not receive a treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propylene glycol
FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,806 Total Patients Enrolled
Alcon ResearchIndustry Sponsor
731 Previous Clinical Trials
128,863 Total Patients Enrolled
Southern College of OptometryOTHER
6 Previous Clinical Trials
306 Total Patients Enrolled
~7 spots leftby Nov 2025
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