KeratoconusNCT02806921
Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes
A study testing ZenLens in people with Keratoconus, run by University of Waterloo.
Trial summary
The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- ZenLens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 15 Feb 2018
- 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
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
Who cannot join
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
- Has undergone any corneal surgery.
- Is participating in any other type of eye related clinical or research study.
- Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
About this study
Official title: Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
Read the detailed description
Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.
- Conditions
- Keratoconus
- Being tested
- ZenLens
- Keywords
- Scleral Contact Lens, Tear Proteases, Tear Cytokines
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenLensDevice
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
| Study group | Role | What they receive |
|---|---|---|
| ZenLens with Low limbal clearance | Active comparator | Scleral contact lens designed to provide approximately 25 microns of limbal clearance. Receives: Device: ZenLens |
| ZenLens with High limbal clearance | Active comparator | Scleral contact lens designed to provide approximately 80 microns of limbal clearance. Receives: Device: ZenLens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Protein
To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
Measured: 2 weeks of lens wear with daily schedule of 6-8 hours.
Secondary outcomes (3)
Comfort
Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses.
Measured: 2 weeks of lens wear with daily schedule of 6-8 hours.
Bulbar and limbal hyperemia
The eyes of the participants will be imaged using the Keratograph® 5.
Measured: 2 weeks of lens wear with daily schedule of 6-8 hours.
Corneal thickness
Their corneal thickness will be measured with the Visante OCT.
Measured: 2 weeks of lens wear with daily schedule of 6-8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion30 Jan 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Luigina Sorbara, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806921
- Sponsor's protocol ID
- 14620
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2016
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
- ClinicalTrials.gov ID
- NCT02806921
- Acronym / sponsor ID
- 14620
- Conditions
- Keratoconus
- Keywords
- Scleral Contact Lens, Tear Proteases, Tear Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Aug 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 21 Jun 2016 (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 purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
Detailed description
Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZenLens with Low limbal clearance | Active comparator | Device: ZenLensScleral contact lens designed to provide approximately 25 microns of limbal clearance. |
| ZenLens with High limbal clearance | Active comparator | Device: ZenLensScleral contact lens designed to provide approximately 80 microns of limbal clearance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
Key exclusion criteria (8 listed)
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
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 |
|---|---|---|
| ZenLensThe ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material. | Device | ZenLens with High limbal clearance, ZenLens with Low limbal clearance |
Primary outcome
Tear Protein
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
3 secondary outcomes
Comfort
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
Bulbar and limbal hyperemia
Time frame: 2 weeks of lens wear with daily schedule of 6-8 hours.
Corneal thickness
Time frame: 2 weeks of lens wear with daily schedule of 6-8 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 27 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ZenLens in people with Keratoconus, run by University of Waterloo.
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 8 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 2 weeks of lens wear with daily schedule of 6-8 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 27 Jun 2019.