Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05314621
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2021-12-17
Brief Title:
A Study Comparing the Efficacy of Pataday Once Daily Relief Extra Strength to Flonase Allergy Relief in Subjects With Allergic Conjunctivitis
Sponsor:
Andover Research Eye Institute
Organization:
Andover Research Eye Institute
Study Overview
Official Title:
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
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None