Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis (NCT03186755) | Clinical Trial Compass
UnknownPhase 4
Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis
Canada42 participantsStarted 2017-06-11
Plain-language 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.
Who can participate
Age range6 Years – 18 Years
SexALL
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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