Phase 3
Completed N=834
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Dry Eye Disease
Source: ClinicalTrials.gov NCT04523129 ↗
Enrolled (actual)
834
Serious AEs
0.6%
Results posted
Mar 2023
Primary outcomePrimary: Change From Baseline in Total Corneal Fluorescein Staining — -3.96; -3.55 score on a scale
◆ Published Evidence
Established
68citations · ~23 / year
Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial.
Summary
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).
Linked Publications
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Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Corneal Fluorescein Staining |
-3.53; -2.97 | — |
| PRIMARY Change From Baseline in Eye Dryness Score |
-12.2; -13.6 | — |
| SECONDARY Change From Baseline in Total Conjunctival Lissamine Green Staining |
-1.24; -0.91 | — |
| SECONDARY Proportion of Responders in Central Corneal Fluorescein Staining Score |
275; 238 | — |
| SECONDARY Proportion of Responders in Total Corneal Fluorescein Staining Score |
293; 236 | — |
| SECONDARY Change From Baseline in Central Corneal Fluorescein Staining |
-0.79; -0.67 | — |
| SECONDARY Change From Baseline in Total Corneal Fluorescein Staining |
-3.53; -2.97 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision |
-7.1; -6.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04523129) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.