Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial Comparing Olopatadine 0.1% Ophthalmic Solution With Hylo-Dual Ophthalmic Preparation in Children With Seasonal Allergic Conjunctivitis

Conditions
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Conjunctivitis, Allergic, Conjunctivitis, Vernal

Intervention / Treatment
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* Drug: Hyaluronic acid 0.05% & Ectoine 2.0%
* Drug: Olopatadine hydrochloride ophthalmic solution 0.1%


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hylo-Dual<br>Hyaluronic acid 0.05% & Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks | Drug: Hyaluronic acid 0.05% & Ectoine 2.0%<br>* Treatment of 1 drop three times a day in both eyes for 8 weeks<br>* Other names: Hylo-Dual;|
| Active Comparator: Patanol<br>Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks | Drug: Olopatadine hydrochloride ophthalmic solution 0.1%<br>* Treatment of 1 drop two times a day in both eyes for 8 weeks<br>* Other names: Patanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of conjunctival erythema | Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). Scale based on the Efron scale. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of conjunctival erythema | Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). Scale based on the Efron scale. | 7 days, 14 days, 30 days, 42 days | 
| Signs of conjunctival chemosis | Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). | 7 days, 14 days, 30 days, 42 days, 56 days | 
| Signs of eyelid swelling | Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement). | 7 days, 14 days, 30 days, 42 days, 56 days | 
| Symptoms of itching, self-rated | Response to the question, How often during the last 3 days did your eyes itch enough that you wanted to rub them? Rated on a 5-point scale. | 7 days, 14 days, 30 days, 42 days, 56 days | 
| Symptoms of redness, self-rated | Rated by patient or parents on an 11-point scale (VAS - Visual Analog Scale) where 0 = no redness and 10 = the most intense redness imaginable. | 7 days, 14 days, 30 days, 42 days, 56 days | 
| Physician's Impression Scale ratings (change scores) | Rated on a 6-point scale: 0 = clinical cure, 1 = satisfactory clinical response, 2 = slight clinical improvement, 3 = clinically unchanged, 4 = slightly clinically worse, and 5 = significantly clinically worse. | 7 days, 14 days, 30 days, 42 days, 56 days | 
| Listing of adverse effects potentially related to the ophthalmic treatment | Based on visual acuity, pupil diameter, intraocular pressure, slit-lamp examination and a dilated fundus examination by an ophthalmologist. | 7 days, 14 days, 30 days, 42 days, 56 days |