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

Sponsor
Michael Marchand, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT03186755
Collaborator
Université de Montréal (Other)
42
Enrollment
1
Location
2
Arms
53.7
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyaluronic acid 0.05% & Ectoine 2.0%
  • Drug: Olopatadine hydrochloride ophthalmic solution 0.1%
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessorsProspective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial Comparing Olopatadine 0.1% Ophthalmic Solution With Hylo-Dual Ophthalmic Preparation in Children With Seasonal Allergic Conjunctivitis
Actual Study Start Date :
Jun 11, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hylo-Dual

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%
Treatment of 1 drop three times a day in both eyes for 8 weeks
Other Names:
  • Hylo-Dual

    		•
    Active Comparator: Patanol

    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%
    Treatment of 1 drop two times a day in both eyes for 8 weeks
    Other Names:
  • Patanol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Signs of conjunctival erythema [56 days]

      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.

    Secondary Outcome Measures

    1. Signs of conjunctival erythema [7 days, 14 days, 30 days, 42 days]

      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.

    2. Signs of conjunctival chemosis [7 days, 14 days, 30 days, 42 days, 56 days]

      Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement).

    3. Signs of eyelid swelling [7 days, 14 days, 30 days, 42 days, 56 days]

      Assessed by an ophthalmologist on slit-lamp examination. 9-point scale consisting of 0.5-unit increments from 0 (normal) to 4 (total involvement).

    4. Symptoms of itching, self-rated [7 days, 14 days, 30 days, 42 days, 56 days]

      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.

    5. Symptoms of redness, self-rated [7 days, 14 days, 30 days, 42 days, 56 days]

      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.

    6. Physician's Impression Scale ratings (change scores) [7 days, 14 days, 30 days, 42 days, 56 days]

      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. Listing of adverse effects potentially related to the ophthalmic treatment [7 days, 14 days, 30 days, 42 days, 56 days]

      Based on visual acuity, pupil diameter, intraocular pressure, slit-lamp examination and a dilated fundus examination by an ophthalmologist.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Sainte-Justine Hospital Montréal Quebec Canada H3T 1C5

    Sponsors and Collaborators

    • Michael Marchand, MD
    • Université de Montréal

    Investigators

    • Principal Investigator: Emilie Goodyear, MD, St. Justine's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michael Marchand, MD, Resident physician in ophthalmology, St. Justine's Hospital
    ClinicalTrials.gov Identifier:
    NCT03186755
    Other Study ID Numbers:
    • 2017-1431
    First Posted:
    Jun 14, 2017
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Conjunctivitis
    Conjunctivitis, Allergic
    Olopatadine Hydrochloride
    Ophthalmic Solutions
    Hyaluronic Acid

    Study Results

    No Results Posted as of Oct 22, 2020