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

NCT ID: NCT05265910

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2022-04-23

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pataday® Once Daily Relief Extra Strength and Placebo tablet

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.

Group Type: ACTIVE_COMPARATOR

olopatadine hydrochloride ophthalmic solution 0.7%

Intervention Type: DRUG

Pataday® Once Daily Relief Extra Strength (eyedrop)

Placebo

Intervention Type: DRUG

Placebo tablet (tablet)

Tears Naturale® II and Claritin® Tablet 24-Hour

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.

Group Type: ACTIVE_COMPARATOR

loratadine 10 mg

Intervention Type: DRUG

Claritin® Tablets 24-Hour (tablet)

Tears Naturale

Intervention Type: DRUG

Tears Naturale® II (eyedrop)

Interventions

olopatadine hydrochloride ophthalmic solution 0.7%

Pataday® Once Daily Relief Extra Strength (eyedrop)

Intervention Type: DRUG

loratadine 10 mg

Claritin® Tablets 24-Hour (tablet)

Intervention Type: DRUG

Tears Naturale

Tears Naturale® II (eyedrop)

Intervention Type: DRUG

Placebo

Placebo tablet (tablet)

Intervention Type: DRUG

Other Intervention Names

Pataday® Once Daily Relief Extra Strength; Claritin® Tablets 24-Hour; Tears Naturale® II; Placebo tablet

Eligibility Criteria

Inclusion Criteria

Each subject must:

1. Be at least 18 years of age at Visit 1 of either gender and any race;

2. Provide written informed consent and sign the HIPAA form;

3. Be willing and able to follow all instructions and attend all study visits;

4. 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;

5. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);

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;

7. (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);

8. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;

9. 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;

10. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2.

Exclusion Criteria

Each subject must not:

1. Have known contraindications or sensitivities to the use of the investigational product or any of its components; 2. 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); 3. 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; 4. Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease; 5. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit; 6. 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
• all other topical ophthalmic preparations (including artificial tears)
• lid scrubs;
• topical prostaglandins or prostaglandin derivatives
• ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days
• inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers; 45 Days
• depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed.

7. Have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens; 8. Have received allergy immunotherapy within the last 2 years; 9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed); 10. Have a history of glaucoma; 11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after; 12. Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial; 13. Be a female who is currently pregnant, planning a pregnancy, or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andover Research Eye Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

21-960-0004

Identifier Type: -

Identifier Source: org_study_id