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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novaliq GmbH
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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