NCT05878067

A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants

A Patient Experience Study With ABBV-444 for Symptom Relief and Tolerability

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	ABBV-444	Lubricant Eye drops

Timeline

• Start date: 2023-06-27
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2023-05-26
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study