Dry Eye SyndromesNCT01434277
Safety Evaluation of a New Preservative in a Lubricating Eye Drop
A study testing Eye Drops with Experimental Preservative in people with Dry Eye Syndromes, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Eye Drops with Experimental Preservative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Eye Drops with Experimental Preservative
- Keywords
- Preservative, Eye Drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Drops with Experimental PreservativeOther
Also called PF-006676
Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks. Receives: Other: Eye Drops with Experimental Preservative |
| 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. Receives: Other: Eye Drops with Experimental Preservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Measured: baseline, Within Two weeks
Change from Baseline in Pre-dose Inferior Staining
Means and Differences from Visit 1 in Pre-Dose Inferior Staining
Measured: 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)
Measured: baseline, Within Two Weeks
Change from Baseline in Pre-Dose Central Staining
Pre-dose Central Staining: Means and Differences from Visit 1
Measured: baseline, Within Two Weeks
Change from Baseline in Pre-Dose Superior Staining
Pre-Dose Superior Staining: Means and Differences from Visit 1
Measured: baseline, Within Two Weeks
Change from Baseline in Pre-Dose Temporal Staining
Pre-dose Temporal Staining: Means and Differences from Visit 1
Measured: baseline, Within Two Weeks
Change from Baseline in Pre-Dose Nasal Staining
Pre-dose Nasal Staining: Means and Differences from Visit 1
Measured: baseline, Within Two Weeks
Change from Baseline in Pre-Dose Average Staining
Pre-dose Average Staining: Means and Differences from Visit 1
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, Within Two Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherryl Frisch, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434277
- Sponsor's protocol ID
- UNKEDI0003
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01434277
- Acronym / sponsor ID
- UNKEDI0003
- Conditions
- Dry Eye Syndromes
- Keywords
- Preservative, Eye Drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Other: Eye Drops with Experimental PreservativeHealthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks. |
| Dry-Eye Subjects | Experimental | Other: Eye Drops with Experimental PreservativeDry-Eye Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Drops with Experimental PreservativeAlso: PF-006676Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42 | Other | Dry-Eye Subjects, Healthy Subjects |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherryl Frisch study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Drops with Experimental Preservative in people with Dry Eye Syndromes, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dose Product Comfort (time frame: baseline, Within Two weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2011.