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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617667
Recruitment Status : Completed
First Posted : December 1, 2015
Results First Posted : July 26, 2018
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novaliq GmbH

Brief 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).

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Cyclosporine A Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: CyclASol Ophthalmic Solution 1
Cyclosporine A solution (dose-level 1) in vehicle
Drug: Cyclosporine A
topical ocular, eye drops
Other Name: Ciclosporin, CsA

Experimental: CyclASol Ophthalmic Solution 2
Cyclosporine A solution (dose-level 2) in vehicle
Drug: Cyclosporine A
topical ocular, eye drops
Other Name: Ciclosporin, CsA

Placebo Comparator: Placebo Ophthalmic Solution
Vehicle only
Drug: Placebo
topical ocular, eye drops
Other Name: Excipient

Active Comparator: Restasis
Cyclosporine A 0.05% ophthalmic emulsion
Drug: Cyclosporine A
topical ocular, eye drops
Other Name: Ciclosporin, CsA




Primary Outcome Measures :
  1. Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days [ Time Frame: Baseline to 113 Days ]
    The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.

  2. Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days [ Time Frame: Baseline to 113 Days ]
    The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617667


Locations
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United States, California
CYS-002 Investigational Site
Newport Beach, California, United States, 92663
United States, Maine
CYS-002 Investigational Site
Lewiston, Maine, United States, 04240
United States, Massachusetts
CYS-002 Investigational Site
Andover, Massachusetts, United States, 01810
CYS-002 Investigational Site
Quincy, Massachusetts, United States, 02169
Sponsors and Collaborators
Novaliq GmbH
Investigators
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Study Director: Sonja Kroesser, Dr.sc.hum. Novaliq GmbH

Additional Information:
Publications of Results:
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Responsible Party: Novaliq GmbH
ClinicalTrials.gov Identifier: NCT02617667    
Other Study ID Numbers: CYS-002
First Posted: December 1, 2015    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: November 6, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Ophthalmic Solutions
Pharmaceutical Solutions
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors