Safety Evaluation of a New Preservative in a Lubricating Eye Drop

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Other: Eye Drops with Experimental Preservative

• Registration Number: NCT01434277
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Last Update Submitted: 2011-09-13
• Study First Posted: 2011-09-14
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Eye Drops with Experimental Preservative	Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
Dry-Eye Subjects	Eye Drops with Experimental Preservative	Dry-Eye Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.

Primary Outcome Measures

Name	Time	Method
Post-dose Product Comfort	baseline, Within Two weeks	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.
Change from Baseline in Pre-Dose Visual Acuity	baseline, Within Two weeks	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.)
Change from Baseline in Pre-dose Inferior Staining	baseline, Within Two weeks	Means and Differences from Visit 1 in Pre-Dose Inferior Staining
Change from Baseline in Mean Corneal Staining	baseline, Within Two Weeks	Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)
Change from Baseline in Pre-Dose Central Staining	baseline, Within Two Weeks	Pre-dose Central Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Superior Staining	baseline, Within Two Weeks	Pre-Dose Superior Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Temporal Staining	baseline, Within Two Weeks	Pre-dose Temporal Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Nasal Staining	baseline, Within Two Weeks	Pre-dose Nasal Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Average Staining	baseline, Within Two Weeks	Pre-dose Average Staining: Means and Differences from Visit 1
Changes in Slit-Lamp Findings: Eye Structure: Lid	Within Two Weeks	Slit-lamp findings were recorded for the Lid ocular structure at 6 time points
Changes in Slit-Lamp Findings: Eye Structure: Lens	baseline, Within Two Weeks	Slit-lamp findings were recorded for the Lens ocular structure at 6 time points
Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva	baseline, Within Two Weeks	Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points
Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea	baseline, Within Two Weeks	Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points

Trial Locations

Locations (1)

ORA, Inc.; 🇺🇸 Andover, Massachusetts, United States