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 Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439394
• Other study ID #: P25-006
• Status: Recruiting
• Start date: May 31, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Optive MEGA-3 (OM3)
Eye Drops

Locations

Country	Name	City	State
United States	Southern College of Optometry /ID# 262668	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

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