NCT05314621

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis

A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Andover Research Eye Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, randomized, double-masked, parallel study.

Detailed description

At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1. For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio: * Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30) * Tears Naturale® II and Flonase® Allergy Relief (n = 30) At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing. At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	olopatadine hydrochloride ophthalmic solution 0.7%)	Pataday® Once Daily Relief Extra Strength (eyedrop)
DRUG	Fluticasone Propionate	Flonase® Allergy Relief (nasal spray)
DRUG	Tears Naturale	Tears Naturale® II (eye drop)
DRUG	Saline nasal spray	Saline nasal spray (nasal spray)

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-07-24
• Completion: 2022-07-24
• First posted: 2022-04-06
• Last updated: 2022-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study