Phase 2
N=101
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01107405 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Ocular Itching — 1.48; 1.84; 1.82; 1.93 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Loteprednol etabonate base (QD) (Drug); Loteprednol etabonate base (BID) (Drug); Loteprednol etabonate base (QID) (Drug); Loteprednol etabonate suspension (Drug); Vehicle of loteprednol etabonate (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
2.02; 1.93; 2.04; 2.17; 2.55; 2.19 | — |
| PRIMARY Conjunctival Redness |
1.96; 2.19; 2.26; 2.22; 2.70; 2.05 | — |
| SECONDARY Ocular Itching |
2.02; 1.93; 2.04; 2.17; 2.55; 2.19 | — |
| SECONDARY Conjunctival Redness |
1.96; 2.19; 2.26; 2.22; 2.70; 2.05 | — |
| SECONDARY Ocular Itching |
2.02; 1.93; 2.04; 2.17; 2.55; 2.19 | — |
| SECONDARY Conjunctival Redness |
1.96; 2.19; 2.26; 2.22; 2.70; 2.05 | — |
Summary
The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.
Eligibility Criteria
Inclusion Criteria
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
- Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.
Exclusion Criteria
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Data sourced from ClinicalTrials.gov (NCT01107405). 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.