CompletedPhase 2

A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

United States718 participantsStarted 2020-10-06

Plain-language summary

The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent must be obtained before any assessment * Adult male or female subjects 18 years of age or older * At least 6 months history of dry eye disease in both eyes * Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis * Composite corneal fluorescein staining score \>= 4 (modified National Eye Institute (NEI) scale) in at least one eye * Schirmer score \>= 1 and =\< 10 mm after 5 minutes in at least one eye * Patients with Sjögren's Syndrome must have dry eye Exclusion Criteria: * Ocular infection in either eye within 30 days prior to Screening * Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit * Use of contact lenses in either eye within 14 days of Screening * Uncontrolled ocular rosacea * Clinically significant conjunctivochalasis in either eye * Other Corneal conditions affecting the corneal structure * Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson Syndrome, sarcoidosis * Currently active, or history of ocular allergies during the time of year the patient will be participating in the study * Patients with current punctal plugs or punctal cauterization or occlusion * Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening. * Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening * Use of ocular, nasal, inhaled, or systemic corticosteroids withi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This was a Phase 2 trial comparing ECF843 to a vehicle control for dry eye — since Phase 2 is mainly about early safety and efficacy signals rather than definitive proof, what do the results so far actually tell us about whether ECF843 worked, and how confident can we be in those findings?
2The trial measured both symptom scores using the SANDE questionnaire and corneal fluorescein staining, which looks at physical damage to the eye's surface — based on what was found, did ECF843 seem to help with symptoms, with actual eye surface healing, or both?
3Since this trial is already completed, is ECF843 available to me now through any other pathway, or would my only option be to wait and see if it moves into a larger Phase 3 trial?
4Given that this study used a vehicle control rather than an existing dry eye treatment as the comparator, how does ECF843 stack up against standard therapies I might already be a candidate for, like cyclosporine or lifitegrast?
5Are there any safety signals or side effects that came up during this trial that you think would be especially relevant to my situation before we consider ECF843 as a future option?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score

Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)

Trial details

NCT IDNCT04391894

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-13

Results submitted2022-05-03

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