Approval Probability
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Ketotifen/naphazoline · 2 trials · 1 indication
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
| Arm | Type | Description |
|---|---|---|
| Ketotifen/naphazoline | EXPERIMENTAL | Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
| Naphazoline | ACTIVE_COMPARATOR | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
| Ketotifen | ACTIVE_COMPARATOR | Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
| KetoNaph | EXPERIMENTAL | KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Ketotifen/naphazoline | DRUG | One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. |
| Naphazoline | DRUG | One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. |
| Ketotifen | DRUG | One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. |
| Vehicle | DRUG | One drop of vehicle ophthalmic solution at visit 3 and visit 4. |
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 b...
Ketotifen/naphazoline is an ophthalmic solution being developed for allergic conjunctivitis. It is a fixed-combination small molecule eye drop studied in the conjunctival allergen challenge model of acute allergic conjunctivitis. Both Phase 3 trials enrolled participants with allergic conjunctivitis in the United States, including children as young as 6 years old.
Ketotifen/naphazoline targets HRH1, the histamine H1 receptor, as an antagonist. Ketotifen acts as an HRH1 antagonist, and naphazoline is included as a decongestant component of the fixed combination. Blocking HRH1 is the mechanism underlying the product's intended activity in allergic conjunctivitis.
Ketotifen/naphazoline is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is the sponsor of the clinical program evaluating the ophthalmic solution in allergic conjunctivitis.
Ketotifen/naphazoline is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently active. The program is investigational and has not been approved by the FDA for allergic conjunctivitis based on the available development information.
Two completed Phase 3 trials studied ketotifen/naphazoline ophthalmic solution in allergic conjunctivitis. NCT00770133 enrolled 141 participants, and NCT00769886 enrolled 144 participants, for a total of 285. Both were randomized, double-blind, placebo-controlled trials conducted in the United States in the conjunctival allergen challenge model.
Both Phase 3 trials of ketotifen/naphazoline used the conjunctival allergen challenge model of allergic conjunctivitis. NCT00770133 and NCT00769886 were randomized, double-blind, and placebo-controlled, enrolling 141 and 144 participants respectively. Participants were 6 years of age and older, of all sexes, and were not healthy volunteers.