Phase 4
N=50
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT02308501 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 — 3.12; 3.02 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lastacaft ® (Drug); Tears Naturale ® (Placebo) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ORA, Inc.
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 |
3.12; 3.02 | — |
| PRIMARY Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2 |
2.44; 2.90 | — |
| SECONDARY Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) |
0.72; 2.19; 0.88; 2.41; 0.91; 2.38 | — |
| SECONDARY Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) |
0.84; 2.00; 1.16; 2.22; 1.19; 2.22 | — |
Summary
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
Eligibility Criteria
Inclusion Criteria
- Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
- Have a positive CAC reaction at Visit 1
- Have a positive conjunctival inflammation score at Visit 1
Exclusion Criteria
- May not use disallowed medications in specified washout period
- May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
- May not have active ocular infection
Data sourced from ClinicalTrials.gov (NCT02308501). 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.