Dry Eye DiseasePhase 3NCT07284381
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
A Phase 3 study testing ABBV-444 and REFRESH OPTIVE UD in people with Dry Eye Disease, run by AbbVie at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- ABBV-444 and REFRESH OPTIVE UD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 20 sitesUnited States
- Study dates
- 15 Dec 2025to 21 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Canyon City Eyecare /ID# 267948
Azusa, California, 91702
Arizona Eye Center - West Ray Road /ID# 267993
Chandler, Arizona, 85224
Scott and Christie and Associates /ID# 268119
Cranberry Township, Pennsylvania, 16066
Trinity Research Group /ID# 279914
Dothan, Alabama, 36301
Global Research Management /ID# 267980
Glendale, California, 91204
Lakeside Vision Center /ID# 268544
Irvine, California, 92604
Moyes Eye Centers /ID# 267944
Kansas City, Missouri, 64154
Lee Shettle Eye and Hearing /ID# 268118
Largo, Florida, 33773
Butchertown Clinical Trials /ID# 267887
Louisville, Kentucky, 40206
Piedmont Eye Center /ID# 267929
Lynchburg, Virginia, 24502
Southern College of Optometry /ID# 267971
Memphis, Tennessee, 38104
Total Eye Care - Memphis /ID# 268327
Memphis, Tennessee, 38119
Clayton Eye Center /ID# 268097
Morrow, Georgia, 30260
Eye Research Foundation /ID# 267931
Newport Beach, California, 92663
Kannarr Eye Care /ID# 267979
Pittsburg, Kansas, 66762
Rochester Ophthalmological Group - Rochester /ID# 268374
Rochester, New York, 14618
Coastal Research Associates - Roswell /ID# 279915
Roswell, Georgia, 30076
Core Inc /ID# 267946
Shelby, North Carolina, 28150
Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939
Smyrna, Tennessee, 37167
Northern New Jersey Eye Institute /ID# 267974
South Orange, New Jersey, 07079
About this study
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
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
Read more
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.
- Conditions
- Dry Eye Disease
- Being tested
- ABBV-444, REFRESH OPTIVE UD
- Keywords
- Dry Eye Disease, ABBV-444
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-444Drug
Topical eye drop
REFRESH OPTIVE UDDrug
Topical eye drop
| Study group | Role | What they receive |
|---|---|---|
| ABBV-444 | Experimental | Participant will receive ABBV-444 as needed but at least twice a day for 90 days. Receives: Drug: ABBV-444 |
| 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) Receives: Drug: REFRESH OPTIVE UD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
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.
Measured: Baseline to Day 90
Number of Participants with Adverse Events (AEs)
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.
Measured: Baseline to Day 90
Secondary outcomes (2)
Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)
Corneal staining will be evaluated in each eye at all visits and will be graded 2 minutes after instillation of the fluorescein, during which time TBUT is measured. Grade staining independently approximately 3 minutes in the 5 zones of the cornea (1 through 5) as shown below based upon a 6-point scale (0,
1, 2, 3, 4, 5) for a maximum grade of 5 in each of the 5 zones (or a total maximal score of 25 for each eye).
Measured: Baseline to Day 90
Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein
The TBUT will be determined during the approximately 3 minutes wait for corneal staining using fluorescein strips moistened with saline drops applied to the treatment area. Participants will be asked to blink normally 2 to 3 times to evenly spread the fluorescein. Then, they will be asked to not blink for as long as they can. As soon as they start holding the blink, the timing with the stopwatch will begin. The stopwatch is stopped on the first occurrence of true tear break-up, not just local thinning or tear film irregularity
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Dec 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284381
- Sponsor's protocol ID
- M23-730
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07284381
- Acronym / sponsor ID
- M23-730
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye Disease, ABBV-444
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-444 | Experimental | Drug: ABBV-444Participant will receive ABBV-444 as needed but at least twice a day for 90 days. |
| REFRESH OPTIVE UD | Active comparator | Drug: REFRESH OPTIVE UDParticipant 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-444Topical eye drop | Drug | ABBV-444 |
| REFRESH OPTIVE UDTopical eye drop | Drug | REFRESH OPTIVE UD |
Primary outcome
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.
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABBV-444 and REFRESH OPTIVE UD in people with Dry Eye Disease, run by AbbVie at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Ocular Surface Disease Index (OSDI) Score (time frame: Baseline to Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.