NCT02617667

CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Novaliq GmbH · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).

Detailed description

This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included. The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED. The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Cyclosporine A	topical ocular, eye drops
DRUG	Placebo	topical ocular, eye drops

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2015-12-01
• Last updated: 2019-11-06
• Results posted: 2018-07-26

Locations

4 sites across 1 country: United States