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

NCT03186755 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2017-1431
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  56 days

Secondary Outcomes (7)

• Signs of conjunctival erythema

  7 days, 14 days, 30 days, 42 days

• Signs of conjunctival chemosis

  7 days, 14 days, 30 days, 42 days, 56 days

• Signs of eyelid swelling

  7 days, 14 days, 30 days, 42 days, 56 days

• Symptoms of itching, self-rated

  7 days, 14 days, 30 days, 42 days, 56 days

• Symptoms of redness, self-rated

  7 days, 14 days, 30 days, 42 days, 56 days

Study Arms (2)

Hylo-Dual

EXPERIMENTAL

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%

Patanol

ACTIVE COMPARATOR

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%

Interventions

Hyaluronic acid 0.05% & Ectoine 2.0% DRUG

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

Also known as: Hylo-Dual

Hylo-Dual

Olopatadine hydrochloride ophthalmic solution 0.1% DRUG

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

Also known as: Patanol

Patanol

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Marchand, MD: lead
• Université de Montréal: collaborator

Study Sites (1)

CHU Sainte-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

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MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Hyaluronic Acid; Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emilie Goodyear, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Marchand, MD

CONTACT

514-805-1247; mic9@sympatico.ca

Emilie Goodyear, MD

CONTACT

514-243-0224; emiliegoodyear@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physician in ophthalmology

Model Details: Prospective, Monocentric, Randomized Controlled Trial, Parallel-group, Single-masked for assessors

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: June 11, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)