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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-05

Study Completion Date

2021-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03292809

Dry Eye Disease

COMPLETED PHASE2/PHASE3

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

NCT04523142

Dry Eye Disease (DED)

COMPLETED PHASE3

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

NCT02617667

Dry Eye Syndromes

COMPLETED PHASE2

A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine

NCT06329661

Dry Eye Disease

COMPLETED PHASE4

NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

NCT00739349

Dry Eye

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CyclASol Ophthalmic Solution

Cyclosporine A solution in vehicle

Group Type EXPERIMENTAL

CyclASol topical ocular, eye drops

Intervention Type DRUG

Cyclosporine A solution in vehicle

Vehicle Ophthalmic solution

Vehicle only

Group Type PLACEBO_COMPARATOR

Vehicle topical ocular, eye drops

Intervention Type DRUG

Vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CyclASol topical ocular, eye drops

Cyclosporine A solution in vehicle

Intervention Type DRUG

Vehicle topical ocular, eye drops

Vehicle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ciclosporine (CSA) Vehicle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No