KeratoconusNCT01416272
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
A study testing KeraSoft IC Soft Contact Lenses in people with Keratoconus, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- KeraSoft IC Soft Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have participated and completed a previous study (ROC2-10-078).
- Is Keratoconic
Who cannot join
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Is not correctable to 20/50 or better in each eye with contact lenses.
- Has greater than Grade 2 slit lamp exam findings.
- Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
- Has any neovascularization within the central 4mm of the cornea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
- Conditions
- Keratoconus
- Being tested
- KeraSoft IC Soft Contact Lenses
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraSoft IC Soft Contact LensesDevice
Lenses will be worn between 8 and 16 hrs each day, for 12 months
| Study group | Role | What they receive |
|---|---|---|
| KeraSoft IC Soft Contact Lenses | Experimental | KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care Receives: Device: KeraSoft IC Soft Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Symptoms and complaints measured on an analog scale
Measured: 4 visits over 1 year
Secondary outcomes (2)
Visual Acuity - Low Contrast
Low contrast visual acuity measured with high ambient illumination (LCHI)
Measured: 4 visits over 1 year
Visual Acuity - High Contrast
High contrast visual acuity measured with high ambient illumination (HCHI)
Measured: 4 visits over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionFeb 2013
Why it stopped: Study was terminated due to a business decision to cancel the entire project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KeratoconusStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Steffen, OD, MS, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416272
- Sponsor's protocol ID
- ROC2-11-024
- Status last verified
- Nov 2014
- First submitted
- 11 Aug 2011
- Last updated
- 25 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT01416272
- Acronym / sponsor ID
- ROC2-11-024
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to a business decision to cancel the entire project.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 25 Nov 2014
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 twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KeraSoft IC Soft Contact Lenses | Experimental | Device: KeraSoft IC Soft Contact LensesKeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have participated and completed a previous study (ROC2-10-078).
- Is Keratoconic
Key exclusion criteria (6 listed)
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Is not correctable to 20/50 or better in each eye with contact lenses.
- Has greater than Grade 2 slit lamp exam findings.
- Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this 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 |
|---|---|---|
| KeraSoft IC Soft Contact LensesLenses will be worn between 8 and 16 hrs each day, for 12 months | Device | KeraSoft IC Soft Contact Lenses |
Primary outcome
Comfort
Time frame: 4 visits over 1 year
Symptoms and complaints measured on an analog scale
2 secondary outcomes
Visual Acuity - Low Contrast
Time frame: 4 visits over 1 year
Visual Acuity - High Contrast
Time frame: 4 visits over 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Keratoconus
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UNITY DX Cornea Study
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
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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.
Robert Steffen, OD, MS study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeraSoft IC Soft Contact Lenses in people with Keratoconus, run by Bausch & Lomb Incorporated 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Nov 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?
Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comfort (time frame: 4 visits over 1 year). 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 25 Nov 2014.