Safety Evaluation of a New Preservative in a Lubricating Eye Drop

A Single-Center Study Evaluating the Safety of a New Preservative in an OTC Lubricant Eye Drop Used QID in Healthy Adults and in Subjects Diagnosed With Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: Eye Drops with Experimental Preservative

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Subjects; Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.	Other: Eye Drops with Experimental Preservative; Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42; Other Names: PF-006676
Experimental: 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.	Other: Eye Drops with Experimental Preservative; Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42; Other Names: PF-006676

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-dose Product Comfort	Product (ocular) comfort was assessed for each eye immediately, and at 1, 2, and 3 minutes following dosing at Visit 1 and 3 using a scale ranging from 0 to 10, where 0 is very uncomfortable and 10 is very comfortable.	baseline, Within Two weeks
Change from Baseline in Pre-Dose Visual Acuity	Change from Baseline in Pre-Treatment Means of Pre-Dose Visual Acuity on the LogMAR scale. (The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale. It measures visual acuity loss; positive values indicate vision loss, while negative values denote normal or better visual acuity.)	baseline, Within Two weeks
Change from Baseline in Pre-dose Inferior Staining	Means and Differences from Visit 1 in Pre-Dose Inferior Staining	baseline, Within Two weeks
Change from Baseline in Mean Corneal Staining	Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)	baseline, Within Two Weeks
Change from Baseline in Pre-Dose Central Staining	Pre-dose Central Staining: Means and Differences from Visit 1	baseline, Within Two Weeks
Change from Baseline in Pre-Dose Superior Staining	Pre-Dose Superior Staining: Means and Differences from Visit 1	baseline, Within Two Weeks
Change from Baseline in Pre-Dose Temporal Staining	Pre-dose Temporal Staining: Means and Differences from Visit 1	baseline, Within Two Weeks
Change from Baseline in Pre-Dose Nasal Staining	Pre-dose Nasal Staining: Means and Differences from Visit 1	baseline, Within Two Weeks
Change from Baseline in Pre-Dose Average Staining	Pre-dose Average Staining: Means and Differences from Visit 1	baseline, Within Two Weeks
Changes in Slit-Lamp Findings: Eye Structure: Lid	Slit-lamp findings were recorded for the Lid ocular structure at 6 time points	Within Two Weeks
Changes in Slit-Lamp Findings: Eye Structure: Lens	Slit-lamp findings were recorded for the Lens ocular structure at 6 time points	baseline, Within Two Weeks
Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva	Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points	baseline, Within Two Weeks
Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea	Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points	baseline, Within Two Weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Investigators: Study Director: Sherryl Frisch, Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): September 14, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Eye Drops; Preservative
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: UNKEDI0003