NCT05265910

A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis

A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (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. In this clinical study, the efficacy comparison between Pataday® Once Daily Relief Extra Strength and Claritin® Tablets 24-Hour will be made using the Ora-CAC model, a validated clinical model accepted by regulatory agents for assessing the efficacy of products on the signs and symptoms of allergic conjunctivitis.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	olopatadine hydrochloride ophthalmic solution 0.7%	Pataday® Once Daily Relief Extra Strength (eyedrop)
DRUG	loratadine 10 mg	Claritin® Tablets 24-Hour (tablet)
DRUG	Tears Naturale	Tears Naturale® II (eyedrop)
DRUG	Placebo	Placebo tablet (tablet)

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-04-23
• Completion: 2022-04-23
• First posted: 2022-03-04
• Last updated: 2022-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study