Dry EyeNCT06443775
An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)
An observational study of Dry Eye, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 14 Oct 2024
- Phase
- Observational
- 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
Study population: Adult participants with dry eye disease and who are high digital device users.
Who may be able to join
- During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study.
- Participant with at least one sign of dry eye:
- Three consecutive tear break-up time (TBUT) tests <= 10 seconds in at least one eye at Screening Visit OR;
- 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 at Screening Visit.
- Use of digital devices of 8 hours or more per day.
- Adult participants who answer yes to the following questions:
- Do you use digital devices at least 8 hours per day? Yes or No
- Are your eyes dry, irritated while using a digital screen like a computer or smartphone? Yes or No
Who cannot join
- Use of artificial tears in the last 24 hours.
- Current use of more than 4 drops of artificial tears per day in each eye.
- Use of dry eye treatment other than artificial tears.
- Are currently on ocular medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis Eye Institute /ID# 263275
Town and Country, Missouri, 60025
About this study
Official title: Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use
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 Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users.
NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.
- Conditions
- Dry Eye
- Being tested
- Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
- Keywords
- Dry Eye, Next Generation Emulsion Preservative Free Eye Drops (NGE-UD), AGN-OPTIVEPLUS
- 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.
Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)Drug
Also called Refresh Digital, Refresh Optive Advanced
Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| NGE-UD | Participants will receive one drop of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Day 1, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Receives: Drug: Next Generation Emulsion Preservative Free Eye Drops (NGE-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 greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.
Measured: Baseline to Day 15
Change from Baseline in Current Symptom Score
The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.'
Measured: Baseline to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Jun 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 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
- NCT06443775
- Sponsor's protocol ID
- P25-007
- Status last verified
- Jul 2025
- First submitted
- 31 May 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience Study Evaluating The Effect of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and QOL in Patients With Mild to Moderate DED and High Digital Device Use
- ClinicalTrials.gov ID
- NCT06443775
- Acronym / sponsor ID
- P25-007
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Next Generation Emulsion Preservative Free Eye Drops (NGE-UD), AGN-OPTIVEPLUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 5 Jun 2024 (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) 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 Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users.
NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States.
There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGE-UD | – | Drug: Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)Participants will receive one drop of Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Day 1, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with dry eye disease and who are high digital device users.
Key inclusion criteria (8 listed)
- During a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study.
- Participant with at least one sign of dry eye:
- Use of digital devices of 8 hours or more per day.
- Adult participants who answer yes to the following questions:
Key exclusion criteria (4 listed)
- Use of artificial tears in the last 24 hours.
- Current use of more than 4 drops of artificial tears per day in each eye.
- Use of dry eye treatment other than artificial tears.
- Are currently on ocular medications.
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 |
|---|---|---|
| Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)Also: Refresh Digital, Refresh Optive AdvancedEye Drops | Drug | NGE-UD |
Primary outcome
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
Time frame: Baseline to Day 15
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 greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.
Change from Baseline in Current Symptom Score
Time frame: Baseline to Day 15
The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.'
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 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by AbbVie at 1 site 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 8 inclusion and 4 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 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 15). 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 14 Jul 2025.