Safety Evaluation of a New Preservative in a Lubricating Eye Drop

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01434277
First received: September 13, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Dry Eye Syndromes
Other: Eye Drops with Experimental Preservative

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Post-dose Product Comfort [ Time Frame: baseline, Within Two weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, Within Two weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, Within Two weeks ] [ Designated as safety issue: No ]
    Means and Differences from Visit 1 in Pre-Dose Inferior Staining

  • Change from Baseline in Mean Corneal Staining [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Pre-dose Central Staining: Means and Differences from Visit 1

  • Change from Baseline in Pre-Dose Superior Staining [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Pre-Dose Superior Staining: Means and Differences from Visit 1

  • Change from Baseline in Pre-Dose Temporal Staining [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Pre-dose Temporal Staining: Means and Differences from Visit 1

  • Change from Baseline in Pre-Dose Nasal Staining [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Pre-dose Nasal Staining: Means and Differences from Visit 1

  • Change from Baseline in Pre-Dose Average Staining [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Pre-dose Average Staining: Means and Differences from Visit 1

  • Changes in Slit-Lamp Findings: Eye Structure: Lid [ Time Frame: Within Two Weeks ] [ Designated as safety issue: No ]
    Slit-lamp findings were recorded for the Lid ocular structure at 6 time points

  • Changes in Slit-Lamp Findings: Eye Structure: Lens [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Slit-lamp findings were recorded for the Lens ocular structure at 6 time points

  • Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points

  • Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea [ Time Frame: baseline, Within Two Weeks ] [ Designated as safety issue: No ]
    Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points


Enrollment: 44
Study Start Date: April 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PF-006676

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434277

Locations
United States, Massachusetts
ORA, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Sherryl Frisch Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01434277     History of Changes
Other Study ID Numbers: UNKEDI0003
Study First Received: September 13, 2011
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Preservative
Eye Drops

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014