---
title: 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
nct_id: NCT07284381
overall_status: RECRUITING
phase: PHASE3
sponsor: AbbVie
study_type: INTERVENTIONAL
primary_condition: Dry Eye Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07284381.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07284381"
ct_last_update_post_date: 2026-03-13
last_seen_at: "2026-05-12T07:16:40.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**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

**NCT ID:** [NCT07284381](https://clinicaltrials.gov/study/NCT07284381)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** AbbVie
- **Conditions:** Dry Eye Disease
- **Start Date:** 2025-12-15
- **Completion Date:** 2026-11
- **CT.gov Last Update:** 2026-03-13

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1).
* Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least 1 eye at both the Screening (Day -7) and Baseline (Day 1) Visits.
* Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both Screening (Day -7) and Baseline (Day 1).
* Have used an artificial tear product for dry eye disease (DED) within 6 months of Screening (Day -7) Visit.

Exclusion Criteria:

* Participant has uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the subject at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.).
* Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) Visit and/or participant anticipates contact lens wear during the study.
* Any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation.
```

## Arms

- **ABBV-444** (EXPERIMENTAL) — Participant will receive ABBV-444 as needed but at least twice a day for 90 days.
- **REFRESH OPTIVE UD** (ACTIVE_COMPARATOR) — Participant will receive REFRESH PLUS as needed but at least twice a day for 90 days. (Refresh Plus is the run-in medication for 7-10 days before study treatment assignment)

## Interventions

- **ABBV-444** (DRUG) — Topical eye drop
- **REFRESH OPTIVE UD** (DRUG) — Topical eye drop

## Primary Outcomes

- **Change from Baseline in Ocular Surface Disease Index (OSDI) Score** _(time frame: Baseline to Day 90)_ — The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement.
- **Number of Participants with Adverse Events (AEs)** _(time frame: Baseline to Day 90)_ — An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

## Secondary Outcomes

- **Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)** _(time frame: Baseline to Day 90)_
- **Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein** _(time frame: Baseline to Day 90)_

## Locations (20)

- Trinity Research Group /ID# 279914, Dothan, Alabama, United States — _RECRUITING_
- Arizona Eye Center - West Ray Road /ID# 267993, Chandler, Arizona, United States — _RECRUITING_
- Canyon City Eyecare /ID# 267948, Azusa, California, United States — _RECRUITING_
- Global Research Management /ID# 267980, Glendale, California, United States — _RECRUITING_
- Lakeside Vision Center /ID# 268544, Irvine, California, United States — _RECRUITING_
- Eye Research Foundation /ID# 267931, Newport Beach, California, United States — _RECRUITING_
- Lee Shettle Eye and Hearing /ID# 268118, Largo, Florida, United States — _RECRUITING_
- Clayton Eye Center /ID# 268097, Morrow, Georgia, United States — _RECRUITING_
- Coastal Research Associates - Roswell /ID# 279915, Roswell, Georgia, United States — _RECRUITING_
- Kannarr Eye Care /ID# 267979, Pittsburg, Kansas, United States — _RECRUITING_
- Butchertown Clinical Trials /ID# 267887, Louisville, Kentucky, United States — _RECRUITING_
- Moyes Eye Centers /ID# 267944, Kansas City, Missouri, United States — _RECRUITING_
- Northern New Jersey Eye Institute /ID# 267974, South Orange, New Jersey, United States — _RECRUITING_
- Rochester Ophthalmological Group - Rochester /ID# 268374, Rochester, New York, United States — _RECRUITING_
- Core Inc /ID# 267946, Shelby, North Carolina, United States — _RECRUITING_
- Scott and Christie and Associates /ID# 268119, Cranberry Township, Pennsylvania, United States — _RECRUITING_
- Southern College of Optometry /ID# 267971, Memphis, Tennessee, United States — _RECRUITING_
- Total Eye Care - Memphis /ID# 268327, Memphis, Tennessee, United States — _RECRUITING_
- Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939, Smyrna, Tennessee, United States — _RECRUITING_
- Piedmont Eye Center /ID# 267929, Lynchburg, Virginia, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `locations.eye research foundation /id# 267931|newport beach|california|united states` — added _(2026-05-12)_
- `locations.lee shettle eye and hearing /id# 268118|largo|florida|united states` — added _(2026-05-12)_
- `locations.clayton eye center /id# 268097|morrow|georgia|united states` — added _(2026-05-12)_
- `locations.coastal research associates - roswell /id# 279915|roswell|georgia|united states` — added _(2026-05-12)_
- `locations.kannarr eye care /id# 267979|pittsburg|kansas|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.trinity research group /id# 279914|dothan|alabama|united states` — added _(2026-05-12)_
- `locations.arizona eye center - west ray road /id# 267993|chandler|arizona|united states` — added _(2026-05-12)_
- `locations.canyon city eyecare /id# 267948|azusa|california|united states` — added _(2026-05-12)_
- `locations.global research management /id# 267980|glendale|california|united states` — added _(2026-05-12)_
- `locations.lakeside vision center /id# 268544|irvine|california|united states` — added _(2026-05-12)_
- `locations.butchertown clinical trials /id# 267887|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.moyes eye centers /id# 267944|kansas city|missouri|united states` — added _(2026-05-12)_
- `locations.northern new jersey eye institute /id# 267974|south orange|new jersey|united states` — added _(2026-05-12)_
- `locations.rochester ophthalmological group - rochester /id# 268374|rochester|new york|united states` — added _(2026-05-12)_
- `locations.core inc /id# 267946|shelby|north carolina|united states` — added _(2026-05-12)_
- `locations.scott and christie and associates /id# 268119|cranberry township|pennsylvania|united states` — added _(2026-05-12)_
- `locations.southern college of optometry /id# 267971|memphis|tennessee|united states` — added _(2026-05-12)_
- `locations.total eye care - memphis /id# 268327|memphis|tennessee|united states` — added _(2026-05-12)_
- `locations.advancing vision research - smyrna - stonecrest parkway /id# 267939|smyrna|tennessee|united states` — added _(2026-05-12)_
- `locations.piedmont eye center /id# 267929|lynchburg|virginia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07284381.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07284381*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*