Safety Evaluation of a New Preservative in a Lubricating Eye Drop

NCT01434277 | Completed

• 1 other identifier: UNKEDI0003
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

Preservative; Eye Drops

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

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

Dry-Eye Subjects

EXPERIMENTAL

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

Interventions

Eye Drops with Experimental Preservative OTHER

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

Also known as: PF-006676

Dry-Eye Subjects; Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

ORA, Inc.

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Sherryl Frisch

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 14, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

US (1)