A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
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| ClinicalTrials.gov Identifier: NCT04391894 |
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Recruitment Status :
Recruiting
First Posted : May 18, 2020
Last Update Posted : February 26, 2021
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The purpose of Part 1 of the study is to determine the safety and efficacy of topical ocular ECF843 compared to topical ocular vehicle for the relief of the signs and symptoms associated with moderate to severe dry eye disease (DED).
Part 2 of the study is exploratory only and intended to explore potential areas of differentiation between ECF843 and Xiidra® (lifitegrast 5% ophthalmic solution) for the treatment of subjects with dry eye disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye | Drug: ECF843 0.45 mg/mL Drug: ECF843 0.15 mg/mL Other: ECF843 vehicle Drug: ECF843 mg/mL Drug: Xiidra® | Phase 2 |
The study will be conducted in 2 parts: Part 1 - efficacy and safety of ECF843 vs vehicle, followed by Part 2 - exploratory assessment of ECF843 vs Xiidra®.
Part 1 uses a double-masked design where subjects will be randomized to receive BID or TID treatment with either ECF843 or vehicle for 56 days.
Part 2 will be initiated only if safety and efficacy of ECF843 during Part 1 is demonstrated. Part 2 uses an open-label design of ECF843 versus Xiidra® for 84 days after a 2-week vehicle run-in phase.
Approximately 800 subjects will need to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period.
For Part 2, it is estimated that up to 200 subjects will need to be screened to randomize up to 160 subjects into the 2 treatment arms.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 680 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Double-masked |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease |
| Actual Study Start Date : | October 6, 2020 |
| Estimated Primary Completion Date : | June 10, 2021 |
| Estimated Study Completion Date : | April 18, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: ECF843 0.45 mg/mL TID or vehicle (Part 1)
Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.
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Drug: ECF843 0.45 mg/mL
Topical ocular eye drop administered 3 times per day (TID) |
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Experimental: ECF843 0.15 mg/mL TID or vehicle (Part 1)
Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.
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Drug: ECF843 0.15 mg/mL
Topical ocular eye drop 2 or 3 times/day (BID orTID) |
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Placebo Comparator: ECF843 vehicle TID (Part 1)
Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.
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Other: ECF843 vehicle
Topical ocular eye drop 2 or 3 times/day (BID orTID) |
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Experimental: ECF843 0.15 mg/mL BID or vehicle (Part 1)
Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.
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Drug: ECF843 0.15 mg/mL
Topical ocular eye drop 2 or 3 times/day (BID orTID) |
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Placebo Comparator: ECF843 vehicle BID (Part 1)
Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.
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Other: ECF843 vehicle
Topical ocular eye drop 2 or 3 times/day (BID orTID) |
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Experimental: ECF843 -Part 2 (concentration/frequency TBD from Part 1)
Randomized in a 1:1 ratio in Part 2. Topical ocular eye drops. Exploratory Arm only.
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Drug: ECF843 mg/mL
Topical ocular eye drop (concentration and dosing frequency to be determined from Part 1). |
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Active Comparator: Xiidra® -Part 2 (5% lifitegrast BID)
Randomized in a 1:1 ratio in Part 2. Topical ocular eye drops. Exploratory Arm only.
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Drug: Xiidra®
Topical ocular eye drop administered twice per day (BID)
Other Name: 5% lifitegrast |
- Part 1: Change from baseline in Symptom Assessment in Dry Eye (SANDE) score [ Time Frame: 56 Days (baseline to End of Part 1) ]The primary aim of the study is to demonstrate improvement in moderate to severe DED with ECF843. This will be evaluated by measuring signs and symptoms as primary estimands. The analysis of the primary estimands will be based on Full Analysis Set (FAS) 1. The two primary estimands are the change from baseline in SANDE symptom score and the change from baseline in composite corneal fluorescein staining score in Part 1.
- Part 1: Change from baseline in composite corneal fluorescein staining score [ Time Frame: 56 Days (baseline to End of Part 1) ]The primary aim of the study is to demonstrate improvement in moderate to severe DED with ECF843. This will be evaluated by measuring signs and symptoms as primary estimands. The analysis of the primary estimands will be based on Full Analysis Set (FAS) 1. The two primary estimands are the change from baseline in SANDE symptom score and the change from baseline in composite corneal fluorescein staining score in Part 1.
- Part 1: Change from baseline in inferior and central corneal fluorescein staining [ Time Frame: 56 Days (baseline to End of Part 1) ]To evaluate the improvement of ECF843 vs vehicle in corneal damage by quadrant
- Part 1: Incidence and severity of ocular and non-ocular adverse events [ Time Frame: 56 Days ]To evaluate the safety of ECF843 vs Vehicle
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
- Corneal conditions
- 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 within 30 days of Screening
- History of malignancy of any organs system
- Pregnant or nursing women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391894
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals |
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04391894 |
| Other Study ID Numbers: |
CECF843A2201 |
| First Posted: | May 18, 2020 Key Record Dates |
| Last Update Posted: | February 26, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dry Eye Sjogrens |
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Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases |
Keratitis Corneal Diseases Lacrimal Apparatus Diseases Lifitegrast Ophthalmic Solutions Pharmaceutical Solutions |