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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Post-dose Product Comfort
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Healthy Subjects
Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
Intervention: Eye Drops with Experimental Preservative (Other)
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.
Intervention: Eye Drops with Experimental Preservative (Other)
Outcomes
Primary Outcomes
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.
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.)
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
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)
Change from Baseline in Pre-Dose Central Staining
Time Frame: baseline, Within Two Weeks
Pre-dose Central Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Superior Staining
Time Frame: baseline, Within Two Weeks
Pre-Dose Superior Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Temporal Staining
Time Frame: baseline, Within Two Weeks
Pre-dose Temporal Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Nasal Staining
Time Frame: baseline, Within Two Weeks
Pre-dose Nasal Staining: Means and Differences from Visit 1
Change from Baseline in Pre-Dose Average Staining
Time Frame: baseline, Within Two Weeks
Pre-dose Average Staining: Means and Differences from Visit 1
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
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
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
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
Secondary Outcomes
No secondary outcomes reported