Phase 3
Completed N=141
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Source: ClinicalTrials.gov NCT00770133 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Ocular Itching — 0.43; 0.40; 1.60; 1.81 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
0.43; 0.40; 1.60; 1.81; 0.65; 0.59 | — |
| PRIMARY Conjunctival Redness |
0.89; 1.49; 1.63; 2.06; 1.13; 1.80 | — |
| SECONDARY Ciliary Redness |
0.81; 1.33; 1.49; 1.05; 1.76; 1.59 | — |
| SECONDARY Episcleral Redness |
0.91; 1.51; 1.65; 1.17; 1.76; 1.68 | — |
| SECONDARY Chemosis |
0.27; 0.28; 0.39; 0.34; 0.46; 0.54 | — |
| SECONDARY Eyelid Swelling |
0.2; 0.2; 0.2; 0.2; 0.2; 0.2 | — |
| SECONDARY Percentage of Eyes With hTearing |
7; 11; 13; 4; 9; 12 | — |
| SECONDARY Percentage of Eyes With Ocular Mucus Discharge |
0; 0; 0; 0; 0; 0 | — |
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 for 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 (NCT00770133). 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. Informational only — not medical advice.