Recruiting

Hylo-Dual vs. Patanol

Sponsor:

Michael Marchand, MD

Code:

NCT03186755

Conditions

Conjunctivitis, Allergic

Conjunctivitis, Vernal

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

Interventions

Hyaluronic acid 0.05% & Ectoine 2.0%

Olopatadine hydrochloride ophthalmic solution 0.1%

Study Details

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.

Conditions

Conjunctivitis, Allergic

Conjunctivitis, Vernal

Study ID

NCT03186755

Start date

Jun 11, 2017

Status verified date

Oct, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hylo-Dual

Hyaluronic acid 0.05% \& Ectoine 2.0% (Hylo-Dual) 1 drop in both eyes 3 times/day for 8 weeks

active comparator: Patanol

Olopatadine hydrochloride ophthalmic solution 0.1% (Olopatadine) 1 drop in both eyes 2 times/day for 8 weeks

Interventions

Hyaluronic acid 0.05% & Ectoine 2.0%

Treatment of 1 drop three times a day in both eyes for 8 weeks

Olopatadine hydrochloride ophthalmic solution 0.1%

Treatment of 1 drop two times a day in both eyes for 8 weeks

Primary outcome measure

  • Signs of conjunctival erythema [ Time Frame: 56 days ]

Central Contacts and Locations

Central contacts

Michael Marchand, MD

514-805-1247mic9@sympatico.ca

Emilie Goodyear, MD

514-243-0224emiliegoodyear@hotmail.com

Locations

CHU Sainte-Justine Hospital

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Michael Marchand, MD

514-805-1247mic9@sympatico.ca

Principal Investigator:

Emilie Goodyear, MD

More Information

Sponsor

Michael Marchand, MD

Last update posted

Oct 26, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Marchand, MD on 2022-10-26.