An Observational Study to Assess Optive MEGA-3 (OM3) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)

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 real-world experiences with Optive MEGA-3 (OM3) on relieving dry eye symptoms in adult participants with DED.

OM3 is an over the counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of OM3 on Day 1 for the acute phase of the study, then 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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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern College of Optometry /ID# 262668

Memphis, Tennessee, 38104-2211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 has at least one of the following signs 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 Screening Visit.

Exclusion criteria

Use of artificial tears in the last 24 hours.
Use of more than 4 drops of artificial tears per day in each eye.
Use of dry eye treatment other than artificial tears.

Treatment and study plan

Optive MEGA-3 (OM3)

Drug

Eye Drops

Other names: Refresh MEGA-3

Primary outcomes

Acute Phase: Change from Baseline in Current Symptom Scores

Time frame: Day 1; Hour 8

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.'
Chronic Phase: Change from Baseline in Ocular Surface Disease Index (OSDI) Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Patient Experience Study Evaluating Effect of OM3 on Dry Eye Symptoms and Quality of Life in Patients With Mild to Moderate Dry Eye Disease

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 3, 2024
Registry last updated: Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed