Phase 2
N=236
Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT01289431 ↗Enrolled (actual)
236
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Ocular Itching — 1.71; 1.34; 2.11; 2.06 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mapracorat (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
1.71; 1.34; 2.11; 2.06; 1.65; 1.58 | — |
| PRIMARY Conjunctival Redness |
2.05; 1.56; 2.01; 1.82; 1.72; 1.81 | — |
| SECONDARY Ciliary Redness |
1.88; 1.39; 1.89; 1.60; 1.58; 1.65 | — |
| SECONDARY Episcleral Redness |
2.11; 1.56; 2.07; 1.85; 1.79; 1.97 | — |
Summary
The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.
Eligibility Criteria
Inclusion Criteria
- positive history of ocular allergies and a positive skin test reaction
- positive bilateral CAC reaction
Exclusion Criteria
- have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
- have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
- had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
- a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
- use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
- have planned surgery during the trial period or within 30 days after.
- have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1
Data sourced from ClinicalTrials.gov (NCT01289431). 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.