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)

Completed

• Conditions: Dry Eye
• Interventions: Drug: Optive MEGA-3 (OM3)

• Registration Number: NCT06439394
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Study Start: 2024-06-17
• Status Verified: 2024-07
• Primary Completion: 2024-07-18
• Study Completion: 2024-07-18
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OM3	Optive MEGA-3 (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.

Primary Outcome Measures

Name	Time	Method
Acute Phase: Change from Baseline in Current Symptom Scores	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	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.

Trial Locations

Locations (1)

Southern College of Optometry /ID# 262668; 🇺🇸 Memphis, Tennessee, United States