Phase 4
Completed N=127
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
Conjunctivitis, Allergic
Source: ClinicalTrials.gov NCT01470118 ↗
Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 — 0.62; 1.01; 2.14; 0.93 Scores on a Scale
Summary
This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 |
0.62; 1.01; 2.14; 0.93; 1.13; 2.35 | — |
| PRIMARY Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 |
0.64; 0.97; 2.27; 0.84; 1.16; 2.19 | — |
| SECONDARY Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
1.74; 1.78; 2.08; 2.01; 2.01; 2.22 | — |
| SECONDARY Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
1.36; 1.47; 1.83; 1.64; 1.67; 2.00 | — |
| SECONDARY Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
1.65; 1.56; 2.01; 1.95; 1.82; 2.15 | — |
| SECONDARY Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
0.90; 0.97; 1.15; 1.03; 1.09; 1.34 | — |
| SECONDARY Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
0.4; 0.4; 1.0; 0.5; 0.6; 1.0 | — |
| SECONDARY Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 |
0.3; 0.4; 1.0; 0.5; 0.6; 0.9 | — |
Eligibility Criteria
Inclusion Criteria
- History of eye allergies within the past 24 months
- Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period
Exclusion Criteria
- Current eye infection
- Eye surgery within 3 months or vision correction surgery within 6 months
- Any planned surgery during the study or 30 days after the study
Data sourced from ClinicalTrials.gov (NCT01470118). 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. Informational only — not medical advice.