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AzTrials

Allergic ConjunctivitisPhase 4NCT05265910

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

A Phase 4 study testing olopatadine hydrochloride ophthalmic solution 0.7%, loratadine 10 mg and Tears Naturale in people with Allergic Conjunctivitis, run by Andover Research Eye Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Allergic Conjunctivitis
What is being tested?
olopatadine hydrochloride ophthalmic solution 0.7%, loratadine 10 mg and Tears Naturale
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteUnited States
Study dates
14 Dec 2021to 23 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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;
  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Andover Eye Associates

    Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: 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

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.

Being tested
olopatadine hydrochloride ophthalmic solution 0.7%, loratadine 10 mg, Tears Naturale, Placebo
Medical subject headings
Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olopatadine hydrochloride ophthalmic solution 0.7%Drug

    Also called Pataday® Once Daily Relief Extra Strength

    Pataday® Once Daily Relief Extra Strength (eyedrop)

  • loratadine 10 mgDrug

    Also called Claritin® Tablets 24-Hour

    Claritin® Tablets 24-Hour (tablet)

  • Tears NaturaleDrug

    Also called Tears Naturale® II

    Tears Naturale® II (eyedrop)

  • PlaceboDrug

    Also called Placebo tablet

    Placebo tablet (tablet)

Study groups in NCT05265910
Study groupRoleWhat they receive
Pataday® Once Daily Relief Extra Strength and Placebo tabletActive comparatorPataday® 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.
Receives: Drug: olopatadine hydrochloride ophthalmic solution 0.7%; Drug: Placebo
Tears Naturale® II and Claritin® Tablet 24-HourActive comparatorTears 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.
Receives: Drug: loratadine 10 mg; Drug: Tears Naturale

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

    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.

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

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

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

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

    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.

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

  5. Ocular itching 7(±1) minutes post-CAC at 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.

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

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

    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.

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

Secondary outcomes (60)

  1. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

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

  2. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  3. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  4. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

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

  5. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  6. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  7. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator at Visit 3.

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

  8. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  9. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  10. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

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

  11. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  12. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  13. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

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

  14. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  15. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  16. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

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

  17. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  18. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  19. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

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

  20. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  21. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  22. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

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

  23. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  24. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  25. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

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

  26. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  27. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  28. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

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

  29. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)

  30. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion

    Nasal congestion evaluated by the subject 0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.

    Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)

  31. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  32. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  33. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness

    Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  34. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  35. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  36. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness

    Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  37. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  38. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  39. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness

    Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  40. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  41. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

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

  42. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Chemosis

    Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  43. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

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

  44. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

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

  45. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Eyelid Swelling

    Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  46. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  47. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  48. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Tearing

    Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  49. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  50. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  51. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Rhinorrhea

    Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  52. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  53. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  54. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Pruritis

    Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  55. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  56. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  57. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis

    Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

  58. Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  59. Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

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

  60. Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Congestion

    Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.

    Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start14 Dec 2021
  3. Primary completion23 Apr 2022
  4. Study completion23 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265910
Sponsor's protocol ID
21-960-0004
Status last verified
Mar 2022
First submitted
14 Dec 2021
Last updated
3 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olopatadine hydrochloride ophthalmic solution 0.7%, loratadine 10 mg and Tears Naturale in people with Allergic Conjunctivitis, run by Andover Research Eye Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular itching 3(±1) minutes post-CAC at Visit 3 (time frame: 3(±1) minutes post-CAC on Day 1 (Visit 3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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