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Hylo-Dual vs Patanol for Allergic Conjunctivitis

Phase 4
Recruiting
Led By Emilie Goodyear, MD
Research Sponsored by Michael Marchand, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current complaint of itching and conjunctival redness in both eyes
Be younger than 65 years old
Must not have
Presence of significant corneal involvement
Autoimmune disease associated with dry eye syndrome (eg, rheumatoid arthritis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days, 14 days, 30 days, 42 days, 56 days
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare the effectiveness of two eye drop medications in treating seasonal allergies in children.

Who is the study for?
This trial is for children aged 6-18 with a history of seasonal allergic conjunctivitis, evidenced by itching and redness in both eyes, and a positive skin reaction to local grass pollen. It excludes those with other eye disorders, sensitivity to study meds, recent use of certain drugs that affect results, or poor vision not correctable to specific standards.
What is being tested?
The study compares Hylo-Dual (Hyaluronic acid & Ectoine) against Olopatadine in treating seasonal allergic conjunctivitis over two months. Participants are randomly assigned to either the Hylo-Dual group or the Olopatadine group.
What are the potential side effects?
Potential side effects may include temporary eye irritation or discomfort, dry eyes, blurred vision after application, and possible hypersensitivity reactions if there's an allergy to any components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently experiencing itching and redness in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My eyes have significant corneal damage.
Select...
I have an autoimmune disease that causes dry eyes.
Select...
I cannot stop taking my current medications, including immunosuppressants or certain antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days, 14 days, 30 days, 42 days, 56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days, 14 days, 30 days, 42 days, 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Signs of conjunctival erythema
Secondary study objectives
Listing of adverse effects potentially related to the ophthalmic treatment
Physician's Impression Scale ratings (change scores)
Signs of conjunctival chemosis
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hylo-DualExperimental Treatment1 Intervention
Hyaluronic acid 0.05% \& Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks
Group II: PatanolActive Control1 Intervention
Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks

Find a Location

Who is running the clinical trial?

Michael Marchand, MDLead Sponsor
Université de MontréalOTHER
221 Previous Clinical Trials
104,238 Total Patients Enrolled
Emilie Goodyear, MDPrincipal InvestigatorSt. Justine's Hospital

Media Library

Hylo-Dual (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03186755 — Phase 4
Allergic Conjunctivitis Research Study Groups: Hylo-Dual, Patanol
Allergic Conjunctivitis Clinical Trial 2023: Hylo-Dual Highlights & Side Effects. Trial Name: NCT03186755 — Phase 4
Hylo-Dual (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03186755 — Phase 4
~0 spots leftby Dec 2024
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