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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) | Drug | Eye Drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.' | Baseline to Day 15 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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Adult participants with dry eye disease and who are high digital device users.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis Eye Institute /ID# 263275 | Town and Country | Missouri | 60025 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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