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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michael Marchand, MD
• Collaborator: Université de Montréal
• Treatments: Hyaluronic Acid; Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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