HealthyNCT00707291
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface
An observational study of Healthy, run by University of Miami at 1 site in United States.
Trial summary
The goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2011
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal healthy subjects
Who may be able to join
- self reported normal subjects
Who cannot join
- any ocular diseases/conditions
- will not wear contact lenses
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing.
Read the detailed description
The goal of this study is to characterize the edge of contact lenses and its interaction with ocular surface.
- Conditions
- Healthy
- Keywords
- contact lens, normal
What is being measured
The primary outcome is the main question the study is designed to answer.
difference characteristics with different contact lenses and different interactions with the eye
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Responsible party
- Principal investigator, Jianhua (Jay) Wang, MD, PhD, University of Miami
- Investigators
- Jianhua Wang, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707291
- Sponsor's protocol ID
- UMOCT9010_Vis_Edge
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2008
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface
- ClinicalTrials.gov ID
- NCT00707291
- Acronym / sponsor ID
- UMOCT9010_Vis_Edge
- Conditions
- Healthy
- Keywords
- contact lens, normal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2008 (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 goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing.
Detailed description
The goal of this study is to characterize the edge of contact lenses and its interaction with ocular surface.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal healthy subjects
Key inclusion criteria (1 listed)
- self reported normal subjects
Key exclusion criteria (2 listed)
- any ocular diseases/conditions
- will not wear contact lenses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference characteristics with different contact lenses and different interactions with the eye
Time frame: 10 hours
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 8 Jul 2014.
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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.
Jianhua Wang, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Miami 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 2 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 8 Jul 2014. 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?
difference characteristics with different contact lenses and different interactions with the eye (time frame: 10 hours). 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 8 Jul 2014.