Safety Evaluation of a New Preservative in a Lubricating Eye Drop

NCT ID: NCT01434277

Last Updated: 2011-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-04-30

Brief Summary

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.

Detailed 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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Healthy Subjects

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

Group Type: EXPERIMENTAL

Eye Drops with Experimental Preservative

Intervention Type: OTHER

Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42

Dry-Eye Subjects

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

Group Type: EXPERIMENTAL

Eye Drops with Experimental Preservative

Intervention Type: OTHER

Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42

Interventions

Eye Drops with Experimental Preservative

Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42

Intervention Type: OTHER

Other Intervention Names

PF-006676

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherryl Frisch

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

ORA, Inc.

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

UNKEDI0003

Identifier Type: -

Identifier Source: org_study_id