Overview

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

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Andover Research Eye Institute
Treatments:
Dextrans
Loratadine
Olopatadine Hydrochloride
Ophthalmic Solutions
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.