N/A
N=847
Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT01987765 ↗Enrolled (actual)
847
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Patients Reporting Adverse Events — 0.13 Percentage of Patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Relestat Ophthalmic Solution 0.05% (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Reporting Adverse Events |
0.13 | — |
| PRIMARY Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale |
5.58; -4.06 | — |
Summary
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.
Eligibility Criteria
Inclusion Criteria
- Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
Exclusion Criteria
- None.
Data sourced from ClinicalTrials.gov (NCT01987765). 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.