Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants.
ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States.
Participants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Start Date27 Jun 2023

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with ABBV-444

100 Translational Medicine associated with ABBV-444

100 Patents (Medical) associated with ABBV-444

Literatures (Medical) associated with ABBV-444

Clinical Optometry

Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms

Article

Author: Sonparote, Sadhana ; Dancey, Charlotte C ; Zhang, Zuoyi ; Ladhani, Omar ; Hom, Milton M ; Liu, Haixia

PurposeDry eye disease (DED) causes discomfort and potential damage to the surface of the eye, commonly managed with artificial tears. We assessed symptom relief, tolerability, and patient experience of a novel carboxymethyl-cellulose-based artificial tear formulation with trehalose and sodium hyaluronate (ABBV-444) in patients with DED.MethodsThis open-label, single-arm, single center study enrolled adult patients with baseline Ocular Surface Disease Index (OSDI) scores of ≥18 and ≤65. Patients were instructed to use ABBV-444 as often as needed but at least twice a day for 30 days. The primary endpoint was change from baseline in OSDI score at Day 30. Secondary endpoints were onset of action (change from baseline in current symptom survey [CSS] visual analog scale [VAS] scores over 5 minutes post administration on Day 1) and patients' experience (change from baseline in Patient Eye Drop Experience [PEDE] survey VAS scores at Day 30). Outcomes were assessed in the per-protocol (PP) population using descriptive statistics. A paired t-test was performed to calculate P-values.ResultsA total of 34 patients were included in the PP population. DED severity, measured by OSDI, significantly decreased by a mean (standard deviation; SD) score of 6.8 (15.0) points from baseline to Day 30 (P=0.006). Patients showed significant symptom improvement as early as 30 seconds after application, with mean (SD) CSS changes from baseline of -3.3 (10.3) points at 30 seconds (P=0.03) and -10.1 (10.6) points at 5 minutes post-dose (P<0.001). No adverse events were reported. PEDE scores averaged between 76.4 (36.7) and 85.7 (21.0) at Day 30.ConclusionContinuous daily treatment with ABBV-444 reduced DED symptom severity over 30 days and demonstrated rapid onset of action within 30 seconds post administration. These results suggest that ABBV-444 is a viable therapy for DED symptoms and support further investigation of longer-term treatment in multicenter trials.

100 Deals associated with ABBV-444

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Dry Eye Syndromes	Phase 3	United States	AbbVie, Inc.	27 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05878067 (CTgov)	Phase 3	Dry Eye Syndromes	40	ABBV-444	dqrkutyrqd(yfsjdqlqiy) = izxvrhaeux kuzjrrjdsd (nxnpjbnxdw, iocncsffsw - fwjibfsxnb) View more	-	15 Oct 2024

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