A Phase 4 interventional study of Hyaluronic acid 0.05% & Ectoine 2.0% and Olopatadine hydrochloride ophthalmic solution 0.1% in Conjunctivitis, Allergic and Conjunctivitis, Vernal, sponsored by Michael Marchand, MD. Status unknown at 1 site in Canada. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Michael Marchand, MD · Phase 4, Interventional, and Treatment
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.
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.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's planned enrollment of 42 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →This is the only study on the registry with Michael Marchand, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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%
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 three times a day in both eyes for 8 weeks
Also known as: Hylo-Dual
Treatment of 1 drop two times a day in both eyes for 8 weeks
Also known as: Patanol
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.
Time frame: 56 days
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days, 14 days, 30 days, 42 days, 56 days
Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.