Overview

This trial is active, not recruiting.

Condition dry eye syndromes
Treatments cyclosporine a, placebo
Phase phase 2
Sponsor Novaliq GmbH
Start date January 2016
End date July 2016
Trial size 207 participants
Trial identifier NCT02617667, CYS-002

Summary

The objective of this study is 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Cyclosporine A solution (dose-level 1) in vehicle
cyclosporine a Ciclosporin, CsA
topical ocular, eye drops
(Experimental)
Cyclosporine A solution (dose-level 2) in vehicle
cyclosporine a Ciclosporin, CsA
topical ocular, eye drops
(Placebo Comparator)
Vehicle only
placebo Excipient
topical ocular, eye drops
(Active Comparator)
Cyclosporine A 0.05% ophthalmic emulsion
cyclosporine a Ciclosporin, CsA
topical ocular, eye drops

Primary Outcomes

Measure
Corneal damage as assessed by fluorescein staining
time frame: 4 months

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document - Patient-reported history of dry eye in both eyes - Current use of over-the-counter and/or prescription eye drops for dry eye symptoms - Ability and willingness to follow instructions, including participation in all study assessments and visits Exclusion Criteria: - Women who are pregnant, nursing or planning a pregnancy - Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control - Clinically significant slit-lamp findings or abnormal lid anatomy at screening - DED secondary to scarring or ocular or periocular malignancy - History of herpetic keratitis - Active ocular allergies or ocular allergies that are expected to be active during the study period - Ongoing ocular or systemic infection at screening or baseline - Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study - History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening - Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period - Presence of an uncontrolled systemic disease - Presence of a known allergy and/or sensitivity to the study drug or its components

Additional Information

Official title 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
Description This phase 2 study will explore 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 will be included. The study will explore 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 will consist of patients suffering from moderate to severe DED.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novaliq GmbH.