Phase 3
N=60
Safety and Efficacy Study of a Eye Drop for Eye Allergy
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00889330 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. — 0.69; 2.27 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- alcaftadine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Vistakon Pharmaceuticals
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. |
0.69; 2.27 | — |
| PRIMARY Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation |
1.96; 2.50 | — |
| PRIMARY Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation |
0.42; 1.90 | — |
| PRIMARY Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation |
1.57; 2.15 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
Eligibility Criteria
Inclusion Criteria
- At least 10 years of age
- positive history of ocular allergies
- positive skin test reaction to allergens.
Exclusion Criteria
- known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
- ocular surgical intervention within three (3) months prior to visit 1 or during the study
- known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
- any other significant illness
Data sourced from ClinicalTrials.gov (NCT00889330). 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.