Phase 4
N=157
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT01732757 ↗Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0 — 0.40; 0.76; 2.00 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alcaftadine 0.25% (Drug); Olopatadine 0.2% (Drug); dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0 |
0.40; 0.76; 2.00 | — |
| SECONDARY Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 |
0.61; 0.79; 2.08; 0.69; 0.71; 1.89 | — |
| SECONDARY Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 |
84.6; 65.4; 21.2; 75.0; 53.8; 21.2 | — |
| SECONDARY Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 |
48.1; 26.9; 5.8; 26.9; 26.9; 3.8 | — |
| SECONDARY Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 |
41.7; 34.3; 8.7; 32.1; 24.0; 10.9 | — |
| SECONDARY Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 |
1.73; 1.61; 2.17; 2.02; 1.81; 2.17 | — |
| SECONDARY Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 |
1.62; 1.47; 2.10; 1.97; 1.71; 2.12 | — |
| SECONDARY Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 |
1.61; 1.53; 2.04; 1.88; 1.70; 2.04 | — |
| SECONDARY Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 |
0.37; 0.27; 0.51; 0.62; 0.51; 0.76 | — |
| SECONDARY Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 |
0.2; 0.3; 0.8; 0.4; 0.5; 0.9 | — |
| SECONDARY Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 |
0.2; 0.4; 0.9; 0.4; 0.5; 0.8 | — |
Summary
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.
Eligibility Criteria
Inclusion Criteria
- History of ocular allergies within the past 24 months.
- Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.
Exclusion Criteria
- Any presence of active ocular infection or history of an ocular herpetic infection.
- Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
- Have any planned surgery during the study or 30 days after the study.
Data sourced from ClinicalTrials.gov (NCT01732757). 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.