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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Experimental | Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Drops with Experimental Preservative | Other | Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherryl Frisch | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORA, Inc. | Andover | Massachusetts | 01810 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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|
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 |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |