Your session is about to expire
← Back to Search
PUFAs and Antioxidants
HydroEye® Supplement for Contact Lens Discomfort
Phase 4
Recruiting
Led By Andrew D Pucker, OD, PhD
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
Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean change at 6 months.
Awards & highlights
Study Summary
This trial will test the efficacy of HydroEye, a dietary supplement, as a treatment for contact lens discomfort.
Who is the study for?
Adults over 18 who wear soft contact lenses daily for at least 6 hours, have dry eye symptoms worsened by lens use, and can follow the study protocol. Participants must not have severe eyelid issues or a history of corneal surgery, take certain medications like anticoagulants regularly, eat lots of fatty fish weekly, or be pregnant.Check my eligibility
What is being tested?
The trial is testing HydroEye®, a dietary supplement with omega fatty acids and antioxidants (vitamins A, E, C), to see if it helps people who experience discomfort from wearing contact lenses due to dry eyes.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include reactions related to ingredients in HydroEye® such as fish oil or vitamins. Allergies or intolerance to these components should be considered.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can see clearly with contact lenses, at least 20/30 vision in both eyes.
Select...
My dry eye symptoms worsen by 25% or more when I wear contact lenses.
Select...
I experience significant dry eye symptoms from wearing contact lenses.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mean change at 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean change at 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Contact Lens Dry Eye Questionnaire (CLDEQ-4)
Secondary outcome measures
Conjunctival Staining
Corneal Staining
Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydroEye®Experimental Treatment1 Intervention
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,312 Total Patients Enrolled
5 Trials studying Contact Lens Complication
227 Patients Enrolled for Contact Lens Complication
Andrew D Pucker, OD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Contact Lens Complication
46 Patients Enrolled for Contact Lens Complication
Kelly K Nichols, OD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see clearly with contact lenses, at least 20/30 vision in both eyes.My dry eye symptoms worsen by 25% or more when I wear contact lenses.I have a condition that causes dry eyes.I have not used fish or certain seed oils in the last 60 days.I have punctal plugs inserted in my tear ducts.I have had surgery on my eye's cornea before.I have used blood thinners, aspirin, NSAIDs, or steroids recently, or I bruise easily.I am willing to stop my current dry eye treatments except for artificial tears for 4 weeks before and during a 6-month study.I experience significant dry eye symptoms from wearing contact lenses.I am willing to stop my current dry eye treatments except for artificial tears for 4 weeks before and during the study.I am 18 years old or older.I have no major eye surface issues causing discomfort.
Research Study Groups:
This trial has the following groups:- Group 1: HydroEye®
- Group 2: Placebo
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential risks associated with HydroEye®?
"HydroEye® has been approved by the FDA, so it receives a score of 3 on our scale."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have used many products with no relief.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger