A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease
Public ClinicalTrials.gov record NCT07284381. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Tear Formulation With REFRESH OPTIVE® Unit Dose in Patients With Dry Eye Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Dry Eye Disease (DED) refers to a long-term condition that happens when there is not enough lubrication in your eyes. This can happen when your eye cannot make enough tears or if you make poor-quality tears. The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (ABBV-444) with Refresh Optive UD for 90 days in participants with Dry Eye Disease (DED. ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). Participants will be placed into 1 of 2 treatment arms. Each group receives different treatment. Adult participants diagnosed with dry eye disease will be enrolled. Around 250 participants will be enrolled in the study at approximately 20 sites across the US In this study, participants first complete a 7-day run-in period using REFRESH PLUS® eye drops. Those eligible are then randomized to receive ABBV-444 eye drops or REFRESH OPTIVE® Unit Dose eye drops. Participants in both arms will receive treatment for a 90-day treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend multiple required study visits during the study at the study site. The effect of the treatment will be checked by medical assessments and questionnaires.
Study identification
- NCT ID
- NCT07284381
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2025 (Actual)
- Primary completion
- Aug 21, 2026 (Actual)
- Completion
- Aug 21, 2026 (Actual)
- Last update posted
- Sep 17, 2026
2025 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trinity Research Group /ID# 279914 | Dothan | Alabama | 36301 | — |
| Arizona Eye Center - West Ray Road /ID# 267993 | Chandler | Arizona | 85224 | — |
| Canyon City Eyecare /ID# 267948 | Azusa | California | 91702 | — |
| Global Research Management /ID# 267980 | Glendale | California | 91204 | — |
| Lakeside Vision Center /ID# 268544 | Irvine | California | 92604 | — |
| Eye Research Foundation /ID# 267931 | Newport Beach | California | 92663 | — |
| Lee Shettle Eye and Hearing /ID# 268118 | Largo | Florida | 33773 | — |
| Clayton Eye Center /ID# 268097 | Morrow | Georgia | 30260 | — |
| Coastal Research Associates - Roswell /ID# 279915 | Roswell | Georgia | 30076 | — |
| Kannarr Eye Care /ID# 267979 | Pittsburg | Kansas | 66762 | — |
| Butchertown Clinical Trials /ID# 267887 | Louisville | Kentucky | 40206 | — |
| Moyes Eye Centers /ID# 267944 | Kansas City | Missouri | 64154 | — |
| Northern New Jersey Eye Institute /ID# 267974 | South Orange | New Jersey | 07079 | — |
| Rochester Ophthalmological Group - Rochester /ID# 268374 | Rochester | New York | 14618 | — |
| Core Inc /ID# 267946 | Shelby | North Carolina | 28150 | — |
| Scott and Christie and Associates /ID# 268119 | Cranberry Township | Pennsylvania | 16066 | — |
| Southern College of Optometry /ID# 267971 | Memphis | Tennessee | 38104 | — |
| Total Eye Care - Memphis /ID# 268327 | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939 | Smyrna | Tennessee | 37167 | — |
| Piedmont Eye Center /ID# 267929 | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07284381, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07284381 live on ClinicalTrials.gov.