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NCT06439394 · ClinicalTrials.gov registry record

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)

A clinical trial, sponsored by AbbVie.

Completed
Registry status
52
Enrollment target

NCT06439394: Completed study, sponsored by AbbVie.

NCT06439394 is a clinical trial that has completed, run by AbbVie. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06439394 has completed, sponsored by AbbVie.

COMPLETED
Registry status
52 participants
Enrollment target

Study 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.

Primary Outcome

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.'

Interventions

  • DRUG Optive MEGA-3 (OM3)

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2024-06-17
Est. Completion 2024-07-18
AbbVie

526 total trials

What the finished NCT06439394 record still lists

NCT06439394 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Optive MEGA-3 (OM3) is the first listed.

NCT06439394 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06439394 about?

NCT06439394 is a clinical study titled "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 i...

What is the current status of trial NCT06439394?

This trial is currently completed. The enrollment target is 52 participants. The study started on 2024-06-17. Estimated completion is 2024-07-18.

What interventions are being tested in trial NCT06439394?

The interventions under investigation include: Optive MEGA-3 (OM3) (DRUG).

Who is sponsoring clinical trial NCT06439394?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT06439394, the US trial registry maintained by the National Library of Medicine. NCT06439394 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.