Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis
NCT ID: NCT03186755
Last Updated: 2022-10-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-11
Study Completion Date
2024-12-31
Brief Summary
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This study compares the efficacy of Hylo-Dual (Hyaluronic acid 0.05% \& Ectoine 2.0%) and Olopatadine (Olopatadine hydrochloride ophthalmic solution 0.1%) in the control of seasonal allergic conjunctivitis in the pediatric population. Half of participants will receive Hylo-Dual, while the other half will receive Olopatadine treatment for 2 months.
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Detailed Description
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Seasonal allergic conjunctivitis (SAC) is an inflammatory response of the conjunctiva triggered by exposure to seasonal allergens. SAC is the most common form of ocular allergy, with an estimated prevalence of approximately 15 to 20%. The distressing signs (redness, chemosis, eyelid swelling) and symptoms (itching, tearing, redness) of SAC may cause extreme discomfort, with a burden due to the frequency and duration of the disease more than to its seriousness.
Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by several comparative studies in adults and children with seasonal allergic conjunctivitis.
Hylo-Dual eye drops is an approved treatment in Canada for children 6 years and older, containing 0.5mg/ml Sodium Hyaluronate, 20mg/ml Ectoine, a borate buffer and water. Ectoine is a natural substance formed by microorganisms to protect themselves from extreme environments (e.g.: salt lakes or hot geysers). They adapt to these conditions by so-called extremolytes, like ectoine, which are osmoprotective substances stabilizing biological membranes. Ectoine has a strong water-binding capacity, forming a physiologic barrier protecting cell membranes from contact with allergenic substances and against inflammatory responses to environmental stress (such as dehydration, e.g. by hyperosmolar tears, UV radiation or airborne allergens). Additionally, ectoine has a stabilizing effect on the lipid phase of the tear film by increasing its elasticity, which causes it to spread evenly over the eye surface and protects against the excessive evaporation of tears.
To the knowledge of the investigators, no systematic interventional prospective study exists comparing the efficacy of Olopatadine and Hylo-Dual for the treatment of seasonal allergic conjunctivitis in the pediatric population. The research question is to determine if both treatment options are equally effective in this population, therefore providing further clinical pharmacologic data relevant to children.
Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by several comparative studies in adults and children with seasonal allergic conjunctivitis.
Hylo-Dual eye drops is an approved treatment in Canada for children 6 years and older, containing 0.5mg/ml Sodium Hyaluronate, 20mg/ml Ectoine, a borate buffer and water. Ectoine is a natural substance formed by microorganisms to protect themselves from extreme environments (e.g.: salt lakes or hot geysers). They adapt to these conditions by so-called extremolytes, like ectoine, which are osmoprotective substances stabilizing biological membranes. Ectoine has a strong water-binding capacity, forming a physiologic barrier protecting cell membranes from contact with allergenic substances and against inflammatory responses to environmental stress (such as dehydration, e.g. by hyperosmolar tears, UV radiation or airborne allergens). Additionally, ectoine has a stabilizing effect on the lipid phase of the tear film by increasing its elasticity, which causes it to spread evenly over the eye surface and protects against the excessive evaporation of tears.
To the knowledge of the investigators, no systematic interventional prospective study exists comparing the efficacy of Olopatadine and Hylo-Dual for the treatment of seasonal allergic conjunctivitis in the pediatric population. The research question is to determine if both treatment options are equally effective in this population, therefore providing further clinical pharmacologic data relevant to children.
Conditions
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Conjunctivitis, Allergic
Conjunctivitis, Vernal
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Caregivers
Outcome Assessors
Study Groups
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Hylo-Dual
Hyaluronic acid 0.05% \& Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks
Group Type
EXPERIMENTAL
Hyaluronic acid 0.05% & Ectoine 2.0%
Intervention Type
DRUG
Treatment of 1 drop three times a day in both eyes for 8 weeks
Patanol
Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks
Group Type
ACTIVE_COMPARATOR
Olopatadine hydrochloride ophthalmic solution 0.1%
Intervention Type
DRUG
Treatment of 1 drop two times a day in both eyes for 8 weeks
Interventions
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Hyaluronic acid 0.05% & Ectoine 2.0%
Treatment of 1 drop three times a day in both eyes for 8 weeks
Intervention Type
DRUG
Olopatadine hydrochloride ophthalmic solution 0.1%
Treatment of 1 drop two times a day in both eyes for 8 weeks
Intervention Type
DRUG
Other Intervention Names
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Hylo-Dual
Patanol
Eligibility Criteria
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Inclusion Criteria
* Children of either sex and any race aged 6 to 18 years
* History of seasonal allergic conjunctivitis lasting at least 1 allergy season (including patients with rhinoconjunctivitis and atopic dermatitis)
* Current complaint of itching and conjunctival redness in both eyes
* Positive skin reaction to at least one common local grass pollen, including Gramineae, at screening or in the 12 months before the study
* History of seasonal allergic conjunctivitis lasting at least 1 allergy season (including patients with rhinoconjunctivitis and atopic dermatitis)
* Current complaint of itching and conjunctival redness in both eyes
* Positive skin reaction to at least one common local grass pollen, including Gramineae, at screening or in the 12 months before the study
Exclusion Criteria
* Another previous or ongoing ocular disorder
* Presence of significant corneal involvement
* Sensitivity to any component of the study medications
* Use of medication between 1 week before the study and study completion that could confound the interpretation of results (i.e. antihistamines, corticosteroids, nonsteroidal anti-inflammatory drugs, mast cell stabilizers, topical ocular vasoconstrictors)
* Participation in other pharmacologic studies during the month before the study
* Poor baseline visual acuity (not correctable to ≥ 0.6 logMAR in both eyes)
* Autoimmune disease associated with dry eye syndrome (eg, rheumatoid arthritis)
* Inability to discontinue wearing contact lenses during the study
* Inability to discontinue the use of concomitant medication: immunosuppressive drugs, sulfa- or neomycin-containing antibiotics, antibiotics causing allergic reaction
* Presence of significant corneal involvement
* Sensitivity to any component of the study medications
* Use of medication between 1 week before the study and study completion that could confound the interpretation of results (i.e. antihistamines, corticosteroids, nonsteroidal anti-inflammatory drugs, mast cell stabilizers, topical ocular vasoconstrictors)
* Participation in other pharmacologic studies during the month before the study
* Poor baseline visual acuity (not correctable to ≥ 0.6 logMAR in both eyes)
* Autoimmune disease associated with dry eye syndrome (eg, rheumatoid arthritis)
* Inability to discontinue wearing contact lenses during the study
* Inability to discontinue the use of concomitant medication: immunosuppressive drugs, sulfa- or neomycin-containing antibiotics, antibiotics causing allergic reaction
Minimum Eligible Age
6 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Université de Montréal
OTHER
Sponsor Role
collaborator
Michael Marchand, MD
OTHER
Sponsor Role
lead
Responsible Party
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Michael Marchand, MD
Resident physician in ophthalmology
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Emilie Goodyear, MD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Locations
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CHU Sainte-Justine Hospital
Montreal, Quebec, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2017-1431
Identifier Type: -
Identifier Source: org_study_id
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