HealthyNCT00347854
Fluorophotometry Evaluation of Lubricant Eye Drops
A study testing Systane Free lubricant eye drops, Visine Tears Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops in people with Healthy, run by Alcon Research at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Systane Free lubricant eye drops, Visine Tears Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2006
- 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
- Ages 18 and over
Who cannot join
- No sodium fluorescein corneal staining at Screening Visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorophotometry Evaluation of Lubricant Eye Drops FID 105783
The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.
- Conditions
- Healthy
- Being tested
- Systane Free lubricant eye drops, Visine Tears Lubricant Eye Drops, Refresh Liquigel Lubricant Eye Drops, Refresh Plus Lubricant Eye Drops
- Keywords
- Normal, healthy eyes (other than correction for visual acuity)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Free lubricant eye dropsOther
Visine Tears Lubricant Eye DropsOther
Refresh Liquigel Lubricant Eye DropsOther
Refresh Plus Lubricant Eye DropsOther
| Study group | Role | What they receive |
|---|---|---|
| FID 105783 | Experimental | Not described Receives: Other: Systane Free lubricant eye drops |
| Visine | Active comparator | Not described Receives: Other: Visine Tears Lubricant Eye Drops |
| Refresh Liquigel | Active comparator | Not described Receives: Other: Refresh Liquigel Lubricant Eye Drops |
| Refresh Plus | Active comparator | Not described Receives: Other: Refresh Plus Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial permeability to fluorescein
Secondary outcomes (1)
tear turnover rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Christensen, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347854
- Sponsor's protocol ID
- C-05-06
- Status last verified
- Feb 2012
- First submitted
- 30 Jun 2006
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.aaopt.org/evaluation-new-preservation-system-corneal-barrier-function
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorophotometry Evaluation of Lubricant Eye Drops FID 105783
- ClinicalTrials.gov ID
- NCT00347854
- Acronym / sponsor ID
- C-05-06
- Conditions
- Healthy
- Keywords
- Normal, healthy eyes (other than correction for visual acuity)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 4 Jul 2006 (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.
The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FID 105783 | Experimental | Other: Systane Free lubricant eye drops |
| Visine | Active comparator | Other: Visine Tears Lubricant Eye Drops |
| Refresh Liquigel | Active comparator | Other: Refresh Liquigel Lubricant Eye Drops |
| Refresh Plus | Active comparator | Other: Refresh Plus Lubricant Eye Drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 18 and over
Key exclusion criteria (1 listed)
- No sodium fluorescein corneal staining at Screening Visit
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 |
|---|---|---|
| Systane Free lubricant eye drops | Other | FID 105783 |
| Visine Tears Lubricant Eye Drops | Other | Visine |
| Refresh Liquigel Lubricant Eye Drops | Other | Refresh Liquigel |
| Refresh Plus Lubricant Eye Drops | Other | Refresh Plus |
Primary outcome
Epithelial permeability to fluorescein
1 secondary outcome
tear turnover rate
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 22 Nov 2016.
- Results publicationhttp://www.aaopt.org/evaluation-new-preservation-system-corneal-barrier-function
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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.
Mike Christensen study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Free lubricant eye drops, Visine Tears Lubricant Eye Drops and Refresh Liquigel Lubricant Eye Drops in people with Healthy, run by Alcon Research 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 1 inclusion and 1 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 22 Nov 2016. 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?
Epithelial permeability to fluorescein. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00347854, which also lists 1 linked publication.
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 22 Nov 2016.