KeratitisCLIKNCT02186431
Contact Lenses and Infiltrative Keratitis
A study testing senofilcon A in people with Keratitis, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratitis
- What is being tested?
- senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2016
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Soft contact lens wearers
- Healthy (control), or with history of infiltrative keratitis (case)
- Has a wearable pair of glasses
- Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism
Who cannot join
- Smoker
- Pregnant or nursing
- Systemic disease that would effect tear proteins
- Punctal plugs
- Use of eye drops in the last week
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY College of Optometry, Clinical Vision Research Center
New York, New York, 10036
About this study
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.
- Conditions
- Keratitis
- Being tested
- senofilcon A
- Keywords
- Contact lenses
- Medical subject headings
- Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
Also called Acuvue Oasys
| Study group | Role | What they receive |
|---|---|---|
| history of corneal infiltrative events | Experimental | To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events Receives: Device: senofilcon A |
| without a history of corneal infiltrative events | Active comparator | To quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events. Receives: Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear protein levels
Measured: After 4-6 hours of daily wear and after one night extended wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Richdale, State University of New York College of Optometry
- Investigators
- Kathryn Richdale, OD, PhD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186431
- Sponsor's protocol ID
- CLIK_601933
- Acronym
- CLIK
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lenses and Infiltrative Keratitis
- ClinicalTrials.gov ID
- NCT02186431
- Acronym / sponsor ID
- CLIK / CLIK_601933
- Conditions
- Keratitis
- Keywords
- Contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jul 2014 (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.
To quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events, to those without a history of complications. This will be accomplished via measurement of select anti-inflammatory tear proteins before, during and after contact lens wear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| history of corneal infiltrative events | Experimental | Device: senofilcon ATo quantify and compare baseline tear proteins and ocular response in contact lens wearers with a history of corneal infiltrative events |
| without a history of corneal infiltrative events | Active comparator | Device: senofilcon ATo quantify and compare baseline tear proteins and ocular response in contact lens wearers without a history of corneal infiltrative events. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Soft contact lens wearers
- Healthy (control), or with history of infiltrative keratitis (case)
- Has a wearable pair of glasses
- Refractive error between +8.00 D and -12.00 D, with less than 1.50 D of astigmatism
Key exclusion criteria (5 listed)
- Smoker
- Pregnant or nursing
- Systemic disease that would effect tear proteins
- Punctal plugs
- Use of eye drops in the last week
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 |
|---|---|---|
| senofilcon AAlso: Acuvue Oasys | Device | history of corneal infiltrative events, without a history of corneal infiltrative events |
Primary outcome
Tear protein levels
Time frame: After 4-6 hours of daily wear and after one night extended wear
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 12 Jul 2016.
Related trials for Keratitis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
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.
Kathryn Richdale, OD, PhD principal investigator
State University of New York College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A in people with Keratitis, run by State University of New York College of Optometry 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 4 inclusion and 5 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 12 Jul 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?
Tear protein levels (time frame: After 4-6 hours of daily wear and after one night extended wear). 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 12 Jul 2016.