CyclASol for the Treatment of Moderate to Severe 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

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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

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).

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 in Subjects Who Completed CYS-004

NCT04523142

Dry Eye Disease (DED)

COMPLETED PHASE3

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

NCT03292809

Dry Eye Disease

COMPLETED PHASE2/PHASE3

CyclASol® Phase 1 Study

NCT02113293

Healthy

COMPLETED PHASE1

Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease

NCT02004067

Primary Sjogren Syndrome Secondary Sjogren Syndrome Aqueous Deficient Dry Eye Disease +1 more

COMPLETED PHASE4

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

NCT04523129

Dry Eye Disease

COMPLETED PHASE3

Detailed Description

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

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.

Conditions

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

Dry Eye Syndromes

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

CyclASol Ophthalmic Solution 1

Cyclosporine A solution (dose-level 1) in vehicle

Group Type EXPERIMENTAL

Cyclosporine A

Intervention Type DRUG

topical ocular, eye drops

CyclASol Ophthalmic Solution 2

Cyclosporine A solution (dose-level 2) in vehicle

Group Type EXPERIMENTAL

Cyclosporine A

Intervention Type DRUG

topical ocular, eye drops

Placebo Ophthalmic Solution

Vehicle only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

topical ocular, eye drops

Restasis

Cyclosporine A 0.05% ophthalmic emulsion

Group Type ACTIVE_COMPARATOR

Cyclosporine A

Intervention Type DRUG

topical ocular, eye drops

Interventions

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

Cyclosporine A

topical ocular, eye drops

Intervention Type DRUG

Placebo

topical ocular, eye drops

Intervention Type DRUG

Other Intervention Names

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

Ciclosporin, CsA Excipient

Eligibility Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No