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CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

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ClinicalTrials.gov Identifier: NCT03292809
Recruitment Status : Active, not recruiting
First Posted : September 26, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Novaliq GmbH

Brief Summary:
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: CyclASol topical ocular, eye drops Drug: Vehicle topical ocular, eye drops Phase 2 Phase 3

Detailed Description:
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CyclASol Ophthalmic Solution
Cylclosporine A solution in vehicle
Drug: CyclASol topical ocular, eye drops
Cyclosporine A solution in vehicle
Other Name: Ciclosporine, CsA
Placebo Comparator: Vehicle Ophthalmic Solution
Vehicle only
Drug: Vehicle topical ocular, eye drops
Vehicle
Other Name: Vehicle



Primary Outcome Measures :
  1. Change in total corneal fluorescein staining [ Time Frame: 1 month ]
  2. Change in Ocular Surface Disease Index [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
  • Patient-reported history of DED in both eyes
  • Current use of OTC (over-the-counter) and/or artificial tears 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 urine pregnancy test at screening and 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
  • Ocular/periocular malignancy
  • History of herpetic keratitis
  • Active ocular allergies or ocular allergies that may become 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 or Liftigrast within 2 months prior to screening
  • Intraocular 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 uncontrolled systemic diseases
  • Presence of 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): NCT03292809


Locations
United States, California
CYS-003 Investigational Site
Newport Beach, California, United States, 92663
CYS-003 Investigational Site
Torrance, California, United States, 90505
United States, Indiana
CYS-003 Investigational Site
Indianapolis, Indiana, United States, 46290
United States, Kentucky
CYS-003 Investigational Site
Louisville, Kentucky, United States, 40206
United States, Massachusetts
CYS-003 Investigational Site
Andover, Massachusetts, United States, 01810
CYS-003 Investigational Site
Raynham, Massachusetts, United States, 02767
United States, Tennessee
CYS-003 Investigational Site
Memphis, Tennessee, United States, 38119
CYS-003 Investigational Site
Nashville, Tennessee, United States, 37205
United States, Virginia
CYS-003 Investigational Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Novaliq GmbH
Investigators
Study Director: Sonja Kroesser, PhD Novaliq GmbH

Responsible Party: Novaliq GmbH
ClinicalTrials.gov Identifier: NCT03292809     History of Changes
Other Study ID Numbers: CYS-003 (ESSENCE)
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Signs and Symptoms
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents