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IVW-1001 Eyelid Wipes for Dry Eye Syndrome
Phase 1 & 2
Recruiting
Research Sponsored by IVIEW Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to voluntarily provide written informed consent to participate in the study
Diagnosis of Dry Eye Disease (DED)
Must not have
History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days
Awards & highlights
Summary
This trial is testing different doses of IVW-1001 in people with dry eye disease, where both the participants and the researchers are unaware of who is receiving which dose.
Who is the study for?
This trial is for adults over 18 with Dry Eye Disease (DED) who can consent to study procedures and visits. It's not for those with high eye pressure, severe corneal staining, history of glaucoma or ocular hypertension treatments, or other inflammatory eye conditions unrelated to DED.
What is being tested?
The trial tests IVW-1001 Ophthalmic Eyelid Wipes at two different strengths (0.1% and 0.2%) against a placebo wipe in people with dry eye disease. It's double-masked so neither participants nor researchers know who gets which treatment.
What are the potential side effects?
Potential side effects are not specified but may include irritation at the application site, allergic reactions, or worsening of dry eye symptoms due to the active ingredients or preservatives in the wipes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can sign the consent form for the study myself.
Select...
I have been diagnosed with Dry Eye Disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had glaucoma or high eye pressure that needed treatment.
Select...
I have eye inflammation not caused by dry eye disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 29 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Schirmer's
Secondary outcome measures
Visual acuity
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: IVW-1001 0.2%Experimental Treatment1 Intervention
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
Group II: IVW-1001 0.1%Experimental Treatment1 Intervention
IVW-1001 Ophthalmic Eyelid Wipe 0.1%
Group III: IVW-1001 PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
IVIEW Therapeutics Inc.Lead Sponsor
3 Previous Clinical Trials
324 Total Patients Enrolled
Bo Liang, PhDStudy DirectorIVIEW Therapeutics Inc.
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