NCT04147650

Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.

Detailed description

This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Conditions

• Dry Eye Syndrome
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	0.05% Voclosporin Ophthalmic Solution (VOS)	0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
DRUG	0.10% VOS	0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
DRUG	0.20% VOS	0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-09-17
• Completion: 2020-10-08
• First posted: 2019-11-01
• Last updated: 2021-12-10
• Results posted: 2021-12-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study