Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis (NCT01743027) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
902 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
* Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
* History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
* Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
* Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
* Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
* Presence of an ocular condition that may affect the study outcomes.
* History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
* Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
* History of anaphylactic reaction to any allerg…
What they're measuring
1
Mean Ocular Itching at Onset of Action
Timeframe: Day 14 (3, 5, and 7 minutes post-CAC)
2
Mean Ocular Itching at 24 Hours Duration of Action