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Also known as Olopatadine
olopatadine/ketorolac tromethamine fixed dose combination · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
| 2 | ACTIVE_COMPARATOR | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution | DRUG | One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days. |
| olopatadine hydrochloride 0.1% ophthalmic solution | DRUG | One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days. |
Inclusion Criteria: * Clinical diagnosis of seasonal allergic conjunctivitis Exclusion Criteria: * Ocular infection or history of ocular herpes infection * History of retinal detachment or diabetic retinopathy * Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immun...
Olopatadine/ketorolac tromethamine fixed dose combination is an investigational ophthalmic solution being developed by AbbVie Inc. (ticker ABBV) for seasonal allergic conjunctivitis and seasonal allergic rhinitis. It combines two small molecule active ingredients in a single eye drop formulation and is currently in Phase 3 clinical development.
It is being studied for seasonal allergic conjunctivitis and seasonal allergic rhinitis, conditions in which allergic inflammation affects the eye and nasal passages. The Phase 3 trial enrolled patients 18 years and older with seasonal allergic conjunctivitis. The combination has not been approved for marketing; it remains an investigational product in clinical development.
The olopatadine component of the fixed dose combination targets HRH1, the histamine H1 receptor, acting as an antagonist. Blocking HRH1 interferes with histamine-driven allergic responses. Ketorolac tromethamine is a nonsteroidal anti-inflammatory component included in the same ophthalmic solution. The combination is designed to address allergic inflammation through these complementary mechanisms.
AbbVie Inc., which trades under the ticker ABBV, is the developer of the olopatadine/ketorolac tromethamine fixed dose combination. The company is advancing the ophthalmic solution as a fixed dose combination product for allergic eye and nasal conditions. No other development partners are identified for this asset.
The olopatadine/ketorolac tromethamine fixed dose combination is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The product is investigational and has not been approved by the FDA for any indication.
The combination has been evaluated in one completed Phase 3 trial, NCT01258309, titled a study of olopatadine hydrochloride/ketorolac tromethamine ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis. The randomized, active-controlled trial enrolled 129 patients in India, aged 18 years and older, and has completed.
No. Olopatadine/ketorolac tromethamine fixed dose combination contains olopatadine plus ketorolac tromethamine, while olopatadine alone is a single-agent product. The Phase 3 trial NCT01258309 compared the fixed dose combination against olopatadine hydrochloride ophthalmic solution as the active control, so the two are distinct treatments.