Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00770133 | Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis. | PHASE3 | COMPLETED | 141 | — | — | Feb 1, 2010 | Jun 1, 2010 | Oct 27, 2020 | 1 | United States |
| NCT00769886 | Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis. | PHASE3 | COMPLETED | 144 | — | — | Oct 1, 2008 | Jun 1, 2009 | Apr 3, 2024 | 1 | United States |
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...