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Safety Evaluation of a New Preservative in a Lubricating Eye Drop

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ClinicalTrials.gov Identifier: NCT01434277
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Other: Eye Drops with Experimental Preservative Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. Post-dose Product Comfort [ Time Frame: 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.

  2. Change from Baseline in Pre-Dose Visual Acuity [ Time Frame: 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.)

  3. Change from Baseline in Pre-dose Inferior Staining [ Time Frame: baseline, Within Two weeks ]
    Means and Differences from Visit 1 in Pre-Dose Inferior Staining

  4. Change from Baseline in Mean Corneal Staining [ Time Frame: baseline, Within Two Weeks ]
    Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)

  5. Change from Baseline in Pre-Dose Central Staining [ Time Frame: baseline, Within Two Weeks ]
    Pre-dose Central Staining: Means and Differences from Visit 1

  6. Change from Baseline in Pre-Dose Superior Staining [ Time Frame: baseline, Within Two Weeks ]
    Pre-Dose Superior Staining: Means and Differences from Visit 1

  7. Change from Baseline in Pre-Dose Temporal Staining [ Time Frame: baseline, Within Two Weeks ]
    Pre-dose Temporal Staining: Means and Differences from Visit 1

  8. Change from Baseline in Pre-Dose Nasal Staining [ Time Frame: baseline, Within Two Weeks ]
    Pre-dose Nasal Staining: Means and Differences from Visit 1

  9. Change from Baseline in Pre-Dose Average Staining [ Time Frame: baseline, Within Two Weeks ]
    Pre-dose Average Staining: Means and Differences from Visit 1

  10. Changes in Slit-Lamp Findings: Eye Structure: Lid [ Time Frame: Within Two Weeks ]
    Slit-lamp findings were recorded for the Lid ocular structure at 6 time points

  11. Changes in Slit-Lamp Findings: Eye Structure: Lens [ Time Frame: baseline, Within Two Weeks ]
    Slit-lamp findings were recorded for the Lens ocular structure at 6 time points

  12. Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva [ Time Frame: baseline, Within Two Weeks ]
    Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points

  13. Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea [ Time Frame: baseline, Within Two Weeks ]
    Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01434277     History of Changes
Other Study ID Numbers: UNKEDI0003
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

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

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