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Completed

NCT Number: NCT01434277

Safety Evaluation of a New Preservative in a Lubricating Eye Drop

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ORA, Inc.

Andover, Massachusetts, 01810, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eye Drops with Experimental Preservative

Other

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

Other names: PF-006676

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2011
Registry last updated
Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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