NCT06178679

Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED)

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	ST-100 (vezocolmitide)	ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml
DRUG	Vehicle	Vehicle Ophthalmic Solution

Timeline

• Start date: 2023-12-29
• Primary completion: 2024-06-30
• Completion: 2024-07-30
• First posted: 2023-12-21
• Last updated: 2024-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study