Phase 3
N=345
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01743027 ↗Enrolled (actual)
345
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Mean Ocular Itching at Onset of Action — 0.38; 0.47; 0.59; 1.91 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AL-4943A ophthalmic solution (Drug); Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug); Olopatadine hydrochloride ophthalmic solution, 0.1% (Drug); AL-4943A ophthalmic solution vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Itching at Onset of Action |
0.38; 0.47; 0.59; 1.91; 0.53; 0.61 | — |
| PRIMARY Mean Ocular Itching at 24 Hours Duration of Action |
1.01; 1.33; 1.53; 2.30; 1.22; 1.48 | — |
| SECONDARY Mean Conjunctival Redness at Onset of Action |
1.34; 1.62; 1.65; 1.96; 1.65; 1.96 | — |
| SECONDARY Mean Conjunctival Redness at 24 Hours Duration of Action |
1.92; 2.01; 1.97; 2.09; 2.04; 2.21 | — |
| SECONDARY Mean Total Redness at Onset of Action |
3.92; 4.73; 4.82; 5.93; 4.80; 5.73 | — |
| SECONDARY Mean Total Redness at 24 Hours Duration of Action |
5.39; 5.77; 5.66; 6.12; 5.87; 6.42 | — |
| SECONDARY Proportion of Ocular Itching Responders at Onset of Action |
71.4; 73.7; 59.6; 10.2 | — |
| SECONDARY Proportion of Itch Responders at 24 Hours Duration of Action |
40.8; 30.3; 26.3; 4.1 | — |
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.
Eligibility Criteria
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 allergens used in this study.
- Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
- Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01743027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.