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 investigational ophthalmic solution being developed for the treatment of allergic conjunctivitis. It is a small molecule drug administered as eye drops. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Ketotifen/naphazoline is being developed by Bausch + Lomb Corporation, which trades on the New York Stock Exchange under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for allergic conjunctivitis.
Ketotifen/naphazoline is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 3 trials have been completed, and the drug remains under investigation for allergic conjunctivitis.
Ketotifen/naphazoline has completed two Phase 3 clinical trials: NCT00769886 and NCT00770133. Both trials evaluated the drug in the conjunctival allergen challenge model of allergic conjunctivitis in the United States, enrolling a total of 285 participants aged 6 years and older.
Ketotifen/naphazoline combines two active ingredients: ketotifen, an antihistamine and mast cell stabilizer, and naphazoline, a decongestant. This combination is designed to relieve itching and redness associated with allergic conjunctivitis by blocking histamine effects and constricting blood vessels in the eye.