ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

March 9, 2023 updated by: Novaliq GmbH

A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
834

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • CYS-004 Investigational Site
    • California
      • Los Angeles, California, United States, 90013
        • CYS-004 Investigational Site
      • Newport Beach, California, United States, 92663
        • CYS-004 Investigational Site
      • Santa Ana, California, United States, 92705
        • CYS-004 Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • CYS-004 Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • CYS-004 Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60619
        • CYS-004 Investigational Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • CYS-004 Investigational Site
      • Indianapolis, Indiana, United States, 46240
        • CYS-004 Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • CYS-004 Investigational Site
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • CYS-004 Investigational Site
      • Raynham, Massachusetts, United States, 02767
        • CYS-004 Investigational Site
    • Minnesota
      • Medina, Minnesota, United States, 55364
        • CYS-004 Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • CYS-004 Investigational Site
      • Kansas City, Missouri, United States, 64154
        • CYS-004 Investigation Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • CYS-004 Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27603
        • CYS-004 Investigational Site
      • Shelby, North Carolina, United States, 28150
        • CYS-004 Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • CYS-004 Investigational Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • CYS-004 Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • CYS-004 Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CYS-004 Investigational Site
      • Smyrna, Tennessee, United States, 37167
        • CYS-004 Investigational Site
    • Utah
      • Layton, Utah, United States, 84041
        • CYS-004 Investigational Site
      • Ogden, Utah, United States, 84403
        • CYS-004 Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • CYS-004 Investigational Site
    • Washington
      • Seattle, Washington, United States, 98119
        • CYS-004 Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed ICF (Informed Consent Form)
  • 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
  • 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
  • Randomized in a previous CyclASol trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CyclASol Ophthalmic Solution
Cyclosporine A solution in vehicle
Drug: CyclASol topical ocular, eye drops
Cyclosporine A solution in vehicle
Other Names:
  • Ciclosporine (CSA)
Placebo Comparator: Vehicle Ophthalmic solution
Vehicle only
Drug: Vehicle topical ocular, eye drops
Vehicle
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Corneal Fluorescein Staining
Time Frame: baseline and 1 month [day 29]
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
baseline and 1 month [day 29]
Change From Baseline in Eye Dryness Score
Time Frame: baseline and 1 month [day 29]
Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
baseline and 1 month [day 29]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Conjunctival Lissamine Green Staining
Time Frame: baseline and 1 month [day 29]
Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye.
baseline and 1 month [day 29]
Proportion of Responders in Central Corneal Fluorescein Staining Score
Time Frame: baseline and 1 month [day 29]
≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
baseline and 1 month [day 29]
Proportion of Responders in Total Corneal Fluorescein Staining Score
Time Frame: baseline and 1 month [day 29]
≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst).
baseline and 1 month [day 29]
Change From Baseline in Central Corneal Fluorescein Staining
Time Frame: baseline and 1 month [day 29]
Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
baseline and 1 month [day 29]
Change From Baseline in Total Corneal Fluorescein Staining
Time Frame: baseline and 2 weeks [day 15]
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
baseline and 2 weeks [day 15]
Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision
Time Frame: baseline and 1 month [day 29]
Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
baseline and 1 month [day 29]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novaliq GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sonja Kroesser, PhD, Novaliq GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CYS-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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