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)

NCT06439394 | Completed FDA Drug

• 1 other identifier: P25-006
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye

Keywords

Dry Eye; OM3; Optive MEGA-3; AGN-OMEGA3

Outcome Measures

Primary Outcomes (2)

• Acute Phase: Change from Baseline in Current Symptom Scores

  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.'

  Day 1; Hour 8

• Chronic Phase: 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.

  Day 15

Study Arms (1)

OM3

Participants will receive 1 drop of OM3 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.

Drug: Optive MEGA-3 (OM3)

Interventions

Optive MEGA-3 (OM3) DRUG

Eye Drops

Also known as: Refresh MEGA-3

OM3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with dry eye disease who are eligible based on the inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Southern College of Optometry /ID# 262668

Memphis, Tennessee, 38104-2211, United States

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: June 17, 2024
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)