drugset / Trial / NCT04910100

Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension

NCT04910100 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety (in the eye and throughout the body) and effectiveness of nebivolol (0.5 and 1 percent) and timolol (0.5 percent) eye drop suspensions. These eye drops will be compared to timolol 0.5 percent eye drop solution in participants with open angle glaucoma (the most common type of glaucoma) or high eye pressure (ocular hypertension).

Timeline

Start
2021-04-15
Primary completion
2022-03-31
Completion
2022-04-29

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Nebivolol Ophthalmic Suspension 1 Percent vs Timolol Ophthalmic Solution 0.5 Percent; Timepoints with Mean IOP < 1.5 mm Hg 0 NCT04910100 ↗

registry analysis (non-inferiority test); Nebivolol Ophthalmic Suspension 0.5 Percent vs Timolol Ophthalmic Solution 0.5 Percent; Timepoints with Mean IOP < 1.5 mm Hg 0 NCT04910100 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nebivolol Other / unclassified 0.5 % Topical
Subject Nebivolol Other / unclassified 1 % Topical
Subject Timolol Other / unclassified 0.5 % Topical