Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05265910
NCT05265910
Completed
Phase 4

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

Andover Research Eye Institute1 site in 1 country58 target enrollmentStarted: December 14, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAllergic Conjunctivitis
Interventionsolopatadine hydrochloride ophthalmic solution 0.7%Placeboloratadine 10 mgTears Naturale
Drugsolopatadine hydrochloride ophthalmic solution 0.7%loratadine 10 mgTears NaturalePlacebo

Overview

Phase
Phase 4
Status
Completed
Sponsor
Andover Research Eye Institute
Enrollment
58
Locations
1
Primary Endpoint
Ocular itching 3(±1) minutes post-CAC at Visit 4b
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

double-masked

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Each subject must:
  • •Be at least 18 years of age at Visit 1 of either gender and any race;
  • •Provide written informed consent and sign the HIPAA form;
  • •Be willing and able to follow all instructions and attend all study visits;
  • •Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;
  • •Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);
  • •Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period;
  • •(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  • •Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
  • •Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1;

Exclusion Criteria

  • •Each subject must not:
  • •Have known contraindications or sensitivities to the use of the investigational product or any of its components;
  • •Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);
  • •Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;
  • •Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
  • •Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
  • •Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study: 7 Days
  • •systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations;
  • •decongestants;
  • •monoamine oxidase inhibitors

Arms & Interventions

Pataday® Once Daily Relief Extra Strength and Placebo tablet

Active Comparator

Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and Placebo tablet will be administered orally (within 5 minutes of eyedrop) at Visits 3 and 4a.

Intervention: olopatadine hydrochloride ophthalmic solution 0.7% (Drug)

Pataday® Once Daily Relief Extra Strength and Placebo tablet

Active Comparator

Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and Placebo tablet will be administered orally (within 5 minutes of eyedrop) at Visits 3 and 4a.

Intervention: Placebo (Drug)

Tears Naturale® II and Claritin® Tablet 24-Hour

Active Comparator

Tears Naturale® II will be administered bilaterally and Claritin® Tablet 24-Hour (loratadine 10 mg) will be administered orally (within 5 minutes of eyedrop) at Visits 3 and 4a.

Intervention: loratadine 10 mg (Drug)

Tears Naturale® II and Claritin® Tablet 24-Hour

Active Comparator

Tears Naturale® II will be administered bilaterally and Claritin® Tablet 24-Hour (loratadine 10 mg) will be administered orally (within 5 minutes of eyedrop) at Visits 3 and 4a.

Intervention: Tears Naturale (Drug)

Outcomes

Primary Outcomes

Ocular itching 3(±1) minutes post-CAC at Visit 4b

Time Frame: 3(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Vi sit 4b.

Ocular itching 3(±1) minutes post-CAC at Visit 3

Time Frame: 3(±1) minutes post-CAC on Day 1 (Visit 3)

Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

Ocular itching 5(±1) minutes post-CAC at Visit 3

Time Frame: 5(±1) minutes post-CAC on Day 1 (Visit 3)

Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

Ocular itching 5(±1) minutes post-CAC at Visit 4b

Time Frame: 5(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.

Ocular itching 7(±1) minutes post-CAC at Visit 3

Time Frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)

Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.

Ocular itching 7(±1) minutes post-CAC at Visit 4b

Time Frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.

Secondary Outcomes

  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Chemosis(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Rhinorrhea(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Pruritis(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion(20(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Tearing(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Rhinorrhea(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion(7(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion(15(±1) minutes post-CAC on Day 1 (Visit 3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Chemosis(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Eyelid Swelling(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Eyelid Swelling(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Rhinorrhea(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Congestion(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Congestion(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Eyelid Swelling(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Tearing(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Tearing(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Pruritis(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Pruritis(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis(7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis(20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))
  • Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Congestion(15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3))

Investigators

Sponsor
Andover Research Eye Institute
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic ConjunctivitisAllergic Conjunctivitis
NCT05314621Andover Research Eye Institute61
Active, not recruiting
Not Applicable
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia ProgressionMyopia, ProgressiveMyopia
NCT05331378Essilor International80
Completed
Phase 2
Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With OsteoporosisOsteoporosis
NCT02592161Korea Health Industry Development Institute166
Completed
Phase 1
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy SubjectsHealthy Subjects
NCT04428814Celltrion271
Completed
Phase 3
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained SubjectsWithdrawal Symptoms
NCT02391571Elite Laboratories, Inc26