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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06439394
Other study ID # P25-006
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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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