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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days, 14 days, 30 days, 42 days, 56 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Listing of adverse effects potentially related to the ophthalmic treatment
Physician's Impression Scale ratings (change scores)
Signs of conjunctival chemosis
+4 more

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
214 Previous Clinical Trials
102,729 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this research initiative?

"To take part in this clinical trial, volunteers must be below 18 years old and have conjunctivitis. In total, 42 individuals need to be recruited for the study."

Answered by AI

Is eligibility to participate in this trial limited by age, and if so what is the cutoff?

"The lower age limit for this trial is 6 and the upper age boundary sits at 18, according to the study's enrolment criteria."

Answered by AI

Are there any other experiments that have utilized Hylo-Dual in their research?

"Presently, 16 medical trials are running studies on Hylo-Dual. Of those experiments, 4 of them have entered the concluding Phase 3 stage. Most of these tests are happening in Morgantown, West Viriginia; however there are 31 different test sites across the United States that offer this treatment."

Answered by AI

Is this investigation enrolling participants at the present time?

"Clinicaltrials.gov indicates that this research study is currently open to participants and has been since June 11th of 2017, with the most recent update occurring on October 24th 2022."

Answered by AI

To what extent should patients be wary of the potential hazards associated with Hylo-Dual?

"There is a wealth of evidence to support the safety profile of Hylo-Dual, resulting in it receiving a score of 3. This is due to its Phase 4 status, signifying that this therapy has been approved for use by regulatory bodies."

Answered by AI

What indications is Hylo-Dual prescribed for?

"Hylo-Dual has the ability to alleviate skin irritation, soothe osteoarthritis (OA), and restore tissue in cases of dermabrasion."

Answered by AI

What is the maximum enrollment number for this experiment?

"Affirmative. Clinicaltrials.gov has the latest information, which indicates that this trial is still recruiting participants after first being posted on June 11th 2017. The clinical team requires 42 patients to be sourced from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis
Michael Marchand, MD 2017. "Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03186755.
~3 spots leftby Dec 2024
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