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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-17

Study Completion Date

2024-10-14

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)

Intervention Type DRUG

Eye Drops

Interventions

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Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)

Eye Drops

Intervention Type DRUG

Other Intervention Names

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Refresh Digital Refresh Optive Advanced

Eligibility Criteria

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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:

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No