Safety Evaluation of a New Preservative in a Lubricating Eye Drop

Johnson & Johnson (J&J)

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Other: Eye Drops with Experimental Preservative

Study type: Interventional

Funder types: Industry

Identifiers

NCT01434277

UNKEDI0003

Details and patient eligibility

About

This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.

Full description

Single-site, open-labeled study. Twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group. Each subject will be in the study for approximately 2 weeks (treatment) and seen at three study Visits: Visit 1 (Day 0, Baseline), Visit 2 (Day 7 +/- 1) and Visit 3 (Day 14 +/- 1). Dosing regimen is 1-2 drops into each eye, four times daily, for two weeks. Assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Able to follow all study instructions and attend all required study visits
• Provide written informed consent
• Visual health and eye comfort within protocol-specified parameters
• Women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study

Exclusion criteria

• Any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results.
• Use of contact lenses outside protocol allowance
• Self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study.
• Participated in an investigational drug or device trial within 30 days of entering the study.

Trial design

44 participants in 2 patient groups

Healthy Subjects

Experimental group

Description:

Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.

Treatment:

Other: Eye Drops with Experimental Preservative

Dry-Eye Subjects

Experimental group

Description:

Dry-Eye Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.

Treatment:

Other: Eye Drops with Experimental Preservative