NCT04523142

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Novaliq GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Detailed description

Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	CyclASol Ophthalmic Solution	Cyclosporine A solution in vehicle

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-04-30
• Completion: 2022-05-23
• First posted: 2020-08-21
• Last updated: 2023-10-16
• Results posted: 2023-10-16

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study