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Timolol/ml eye · 2 trials · 2 indications
Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..
| Arm | Type | Description |
|---|---|---|
| AZARGA | EXPERIMENTAL | Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| AZOPT + Timolol | ACTIVE_COMPARATOR | Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator. |
| Brinzolamide +Timolol | EXPERIMENTAL | - |
| Brinzolamide | ACTIVE_COMPARATOR | - |
| Timolol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension | DRUG | - |
| Brinzolamide 1% ophthalmic suspension | DRUG | - |
| Timolol 0.5% ophthalmic solution | DRUG | - |
| Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension | DRUG | One drop twice daily in each study eye for six months |
| Timolol 5 mg/ml eye drops, solution | DRUG | One drop twice daily in each study eye for six months |
Inclusion Criteria: * Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy. * Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit. * Willing to sign an Informed Consent form. * Contact lens wearer who ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |
Timolol/ml eye is an investigational ophthalmic solution being developed for open-angle glaucoma. It is a small molecule therapy in Phase 3 clinical development. The drug is intended to lower intraocular pressure in patients with this condition, though it remains investigational and has not been approved by regulatory authorities.
Timolol/ml eye is being developed by Alcon Inc., a company traded under the ticker ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of this ophthalmic formulation for the treatment of open-angle glaucoma. The drug is currently in Phase 3 development.
Timolol/ml eye is in Phase 3 clinical development. It is an investigational drug for open-angle glaucoma and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed, with a total of 851 patients enrolled across both studies.
Timolol/ml eye has been studied in two completed Phase 3 trials. NCT00314158 enrolled 523 patients with open-angle glaucoma or ocular hypertension in the United States. NCT01357616 enrolled 328 patients comparing a fixed combination of brinzolamide and timolol versus separate administration. Both trials were randomized, double-blind, and active-controlled.
Timolol/ml eye is a single-agent formulation containing timolol. One of its Phase 3 trials, NCT01357616, compared a fixed combination of brinzolamide 1% and timolol 0.5% against separate administration of the two drugs. However, Timolol/ml eye itself is not a combination product.