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)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-17

Study Completion Date

2024-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

NCT02553772

Dry Eye Syndromes

COMPLETED PHASE3

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

NCT03162783

Dry Eye Syndromes

COMPLETED PHASE2

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)

NCT06443775

Dry Eye

COMPLETED

Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome

NCT03162094

Dry Eye Syndrome

UNKNOWN PHASE1/PHASE2

Dry Eye Disease Study With Brimonidine

NCT03418727

Dry Eye

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Optive MEGA-3 (OM3)

Intervention Type DRUG

Eye Drops

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optive MEGA-3 (OM3)

Eye Drops

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Refresh MEGA-3

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No