Clinical trial NCT01434277: Safety Evaluation of a New Preservative in a Lubricating Eye Drop
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Preservative
Eye Drops
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

Primary outcomes:
measure: Post-dose Product Comfort
timeFrame: baseline, Within Two weeks
measure: Change from Baseline in Pre-Dose Visual Acuity
timeFrame: baseline, Within Two weeks
measure: Change from Baseline in Pre-dose Inferior Staining
timeFrame: baseline, Within Two weeks
measure: Change from Baseline in Mean Corneal Staining
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Pre-Dose Central Staining
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Pre-Dose Superior Staining
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Pre-Dose Temporal Staining
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Pre-Dose Nasal Staining
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Pre-Dose Average Staining
timeFrame: baseline, Within Two Weeks
measure: Changes in Slit-Lamp Findings: Eye Structure: Lid
timeFrame: Within Two Weeks
measure: Changes in Slit-Lamp Findings: Eye Structure: Lens
timeFrame: baseline, Within Two Weeks
measure: Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva
timeFrame: baseline, Within Two Weeks
measure: Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea
timeFrame: baseline, Within Two Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: ORA, Inc.
state: Massachusetts
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Sherryl Frisch
role: STUDY_DIRECTOR
References: