Phase 3
N=202
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01479374 ↗Enrolled (actual)
202
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Mean Ocular Itching at Onset of Action — 0.4; 1.9; 0.4; 0.6 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AL-4943A ophthalmic solution (Drug); AL-4943A vehicle (Drug); Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Itching at Onset of Action |
0.4; 1.9; 0.4; 0.6; 2.1; 0.7 | — |
| PRIMARY Mean Ocular Itching at 16 Hours Duration of Action |
0.7; 2.2; 0.9; 0.8; 2.3; 1.1 | — |
| SECONDARY Mean Conjunctival Redness at Onset of Action |
0.8; 2.1; 1.3; 1.1; 2.3; 1.9 | — |
| SECONDARY Mean Conjunctival Redness at 16 Hours Duration of Action |
1.3; 1.8; 1.6; 1.5; 1.9; 1.9 | — |
| SECONDARY Mean Total Redness at 24 Hours Duration of Action |
4.1; 6.1; 5.4; 5.0; 6.7; 6.2 | — |
| SECONDARY Mean Ocular Itching at 24 Hours Duration of Action |
0.9; 2.5; 1.4; 1.1; 2.6; 1.5 | — |
| SECONDARY Mean Conjunctival Redness at 24 Hours Duration of Action |
1.5; 2.1; 1.9; 1.8; 2.3; 2.1 | — |
Summary
The purpose of this study was to assess the safety and efficacy of AL-4943A 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.
- Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
- History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
- Positive bilateral CAC response at Visit 1 and Visit 2.
- 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 requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
- Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
- Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
- Any contraindications or hypersensitivities to the use of the study medication or their components.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01479374). 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.