CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 411 enrolled
Drug / intervention
Timolol maleate Ophthalmic Solution 0.5% BID +2 moredrug
Likely dose
AR-13324 Ophthalmic Solution 0.02%, 1 drop once daily (QD) in the evening, both eyes (OU)AI-extracted
Key inclusion· 5
  • ✓Age 0–2 years or ≥18 years
  • ✓Diagnosis of open-angle glaucoma or ocular hypertension
  • ✓Unmedicated (post-washout) IOP >20 mmHg and <27 mmHg in study eye at 2 qualification visits
  • ✓Corrected visual acuity in each eye equivalent to 20/200 or better
Key exclusion· 16
  • ✕Pseudoexfoliation, pigment dispersion component, history of angle closure, or narrow angles (prior laser peripheral iridotomy not acceptable)
  • ✕Unmedicated IOP ≥27 mmHg in both eyes OR use of >2 ocular hypotensive medications within 30 days of screening
  • ✕Known hypersensitivity to benzalkonium chloride, topical anesthetics, or beta-adrenoceptor antagonists
  • ✕Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02207491
NCT02207491Phase 3Completed
CompareCT.gov

A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% Compared to Timolol Maleate Ophthalmic Solution, 0.5% in Patients With Elevated Intraocular Pressure

Aerie Pharmaceuticals·interventional·Posted Aug 4, 2014·Updated Apr 13, 2018

In Brief

A Phase 3 clinical trial evaluating Timolol maleate Ophthalmic Solution 0.5% BID, AR-13324 Ophthalmic Solution 0.02%, and 1 other intervention for Ocular Hypertension and Open-angle Glaucoma. Completed, enrolled 411 participants across 1 site.

Detailed Summary

To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Hypertension, Open-angle Glaucoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartJul 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.9 years ago

Interventions

Timolol maleate Ophthalmic Solution 0.5% BIDdrug

1 drop BID, AM/PM, OU

AR-13324 Ophthalmic Solution 0.02%drug

1 drop once daily (QD), PM, OU

Placeboother

1 drop QD, AM, OU