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ECF843 · 1 trial · 1 indication
The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.
The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.
| Arm | Type | Description |
|---|---|---|
| ECF843 0.45 mg/mL TID or vehicle (Part 1) | EXPERIMENTAL | ECF843 0.45 mg/mL TID or vehicle (Part 1) |
| ECF843 0.15 mg/mL TID or vehicle (Part 1) | EXPERIMENTAL | ECF843 0.15 mg/mL TID or vehicle (Part 1) |
| ECF843 vehicle TID (Part 1) | PLACEBO_COMPARATOR | ECF843 vehicle TID (Part 1) |
| ECF843 0.15 mg/mL BID or vehicle (Part 1) | EXPERIMENTAL | ECF843 0.15 mg/mL BID or vehicle (Part 1) |
| ECF843 vehicle BID (Part 1) | PLACEBO_COMPARATOR | ECF843 vehicle BID (Part 1) |
| Name | Type | Description |
|---|---|---|
| ECF843 | DRUG | Topical ocular eye drop |
| ECF843 vehicle | OTHER | Topical ocular eye drop |
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 * Compo...
ECF843 is an investigational small molecule being developed for the treatment of Dry Eye, also known as Dry Eye Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
ECF843 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for Dry Eye Disease.
ECF843 is in Phase 2 clinical development. It is an investigational drug for Dry Eye Disease and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed.
ECF843 has one completed Phase 2 clinical trial, identified as NCT04391894. This study assessed the safety and efficacy of ECF843 compared to a vehicle control in 718 subjects with Dry Eye Disease in the United States.
No, ECF843 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Dry Eye Disease. The completed Phase 2 trial, NCT04391894, evaluated its safety and efficacy but did not lead to approval.