Safety Evaluation of a New Preservative in a Lubricating Eye Drop

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Other: Eye Drops with Experimental Preservative


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>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<br>* Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42<br>* Other names: PF-006676;|
| Experimental: Dry-Eye Subjects<br>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<br>* Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42<br>* Other names: PF-006676;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preservative, Eye Drops