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Artificial Tears
Systane Complete PF (Treatment) for Dry Eye Syndrome (AlconAT Trial)
Phase 4
Waitlist Available
Led By Meng C. Lin, OD, PhD
Research Sponsored by University of California, Berkeley
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 deq-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing different types of eye drops, including some with special oils, to see which ones work best for adults with dry eyes. The special oils help keep the eyes moist by improving the stability of the tear film.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ deq-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~deq-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tear Lipid Layer Thickness
Secondary study objectives
Tear Film Thinning Rate
Tear Lipid Layer Uniformity
Other study objectives
Exploratory - Subjective Symptoms - DEQ-5
Exploratory - Subjective Symptoms - OSDI
Exploratory - Subjective Symptoms - SANDE
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Systane Complete PF (Treatment)Experimental Treatment1 Intervention
Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.
Group II: CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)Active Control1 Intervention
Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.
Group III: Refresh Optive Mega-3 PF (Active Comparator 1)Active Control1 Intervention
Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.
Group IV: Refresh Relieva PF (Control)Placebo Group1 Intervention
Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Systane Complete PF
2023
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
186 Previous Clinical Trials
640,664 Total Patients Enrolled
Alcon ResearchIndustry Sponsor
731 Previous Clinical Trials
128,825 Total Patients Enrolled
Meng C. Lin, OD, PhDPrincipal InvestigatorUniversity of California Berkeley Clinical Research Center
1 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition or are taking prescription medication that can affect your eyes' natural lubrication.You currently wear contact lenses.You have a history of serious eye injury, eye surgery, or diabetes.You have a medical condition or situation that can put you at risk or make it difficult for you to participate in the study.You have an eye infection or inflammation happening right now.You have dry eyes and your symptoms are moderate to severe (score of 13 or higher on a questionnaire).
Research Study Groups:
This trial has the following groups:- Group 1: Systane Complete PF (Treatment)
- Group 2: Refresh Relieva PF (Control)
- Group 3: CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)
- Group 4: Refresh Optive Mega-3 PF (Active Comparator 1)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05705518 — Phase 4
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