Glaukos Announces Positive Topline Results from Phase 4 Prospective Randomized Controlled Clinical Trial Evaluating iDose® TR in Combination with Cataract Surgery
Glaukos announced positive topline results from a Phase 4 randomized controlled trial of iDose TR administered in combination with cataract surgery in patients with open-angle glaucoma or ocular hypertension. At month 3, the iDose TR arm achieved a mean diurnal IOP reduction of 11.1 mmHg versus 7.4 mmHg for cataract surgery alone, a statistically significant incremental effect of 3.6 mmHg (p<0.0001) across 149 randomized eyes.
Key figures
- Drug Name
- iDose TR (travoprost intracameral implant)
- Phase Of Trial
- Phase 4
- P value
- p<0.0001
- Eyes randomized
- 149
- Control arm eyes
- 75
- Treatment arm eyes
- 74
- Mean iop reduction control mm Hg
- 7.4
- Incremental treatment effect mm Hg
- 3.6
- Mean iop reduction treatment mm Hg
- 11.1
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