Phase 3
N=144
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00769886 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Ocular Itching — 0.50; 0.49; 1.87; 1.93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketotifen/naphazoline (Drug); Ketotifen (Drug); Naphazoline (Drug); Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
0.50; 0.49; 1.87; 1.93; 0.56; 0.69 | — |
| PRIMARY Conjunctival Hyperemia |
1.13; 1.49; 1.62; 2.24; 1.39; 1.89 | — |
| SECONDARY Ciliary Redness |
1.05; 1.39; 1.66; 1.28; 1.79; 1.71 | — |
| SECONDARY Episcleral Redness |
1.21; 1.52; 1.71; 1.41; 1.87; 1.77 | — |
| SECONDARY Chemosis |
0.22; 0.22; 0.51; 0.29; 0.42; 0.66 | — |
| SECONDARY Eyelid Swelling |
0.13; 0.32; 0.61; 0.25; 0.37; 0.61 | — |
| SECONDARY Percentage of Eyes With Tearing |
3; 11; 23; 6; 7; 16 | — |
| SECONDARY Percentage of Eyes With Ocular Mucus Drainage |
7; 12; 13; 11; 19; 18 | — |
Summary
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
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 0.7 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 at least 2 out of 3 time points 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 (NCT00769886). 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.