KeratoconusPhase 1NCT02009709
Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
A Phase 1 study testing Riboflavin 0.1% ophthalmic solution, CCL-VARIO UV lamp and CCL-VARIO at 18 mW/cm2 in people with Keratoconus and Corneal Ectasia, run by Robert Mack, M.D. at 1 site in United States.
Trial summary
The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin 0.1% ophthalmic solution, CCL-VARIO UV lamp and CCL-VARIO at 18 mW/cm2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2017
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective subjects must meet two of the following criteria:
- Having a diagnosis of progressive keratoconus:
- An increase of ≥ 1.00 D in the steepest keratometry value
- An increase of ≥ 1.00 D in astigmatism manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Presence of central or inferior steepening on the Pentacam map.
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- Axial topography consistent with keratoconus
- Steepest keratometry (Kmax) value ≥ 47.00 D
- Prospective subjects must meet the following criteria:
- History of having undergone a keratorefractive procedure
- Meeting two of the following criteria
- Steepening by topography, either Pentacam or Humphrey
- Thinning of cornea
- Shift in the position of thinnest portion of cornea
- Change in refraction with increasing myopia
- Development of myopic astigmatism
- Development of irregular astigmatism
- Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria
- Subjects meeting any of the following criteria will be excluded from this protocol:
- Eyes classified as either normal, atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye to be treated
- A history of chemical injury or delayed epithelial healing in the eye to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment
- Inability to cooperate with diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mack Eye Center
Hoffman Estates, Illinois, 60169
Adam Baruch, 847-755-9393, adam@mackeyecenter.com
Robert J Mack, M.D.
About this study
Official title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia
The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin 0.1% ophthalmic solution, CCL-VARIO UV lamp, CCL-VARIO at 18 mW/cm2
- Keywords
- keratoconus, collagen crosslinking, crosslinking, ectasia
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin 0.1% ophthalmic solutionDrug
Also called CXL, CCL, crosslinking
Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
CCL-VARIO UV lampDevice
Also called CXL, CCL, crosslinking
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
CCL-VARIO at 18 mW/cm2Device
Also called CXL, CCL, crosslinking
Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 9 mW/cm2 | Active comparator | CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution Receives: Drug: Riboflavin 0.1% ophthalmic solution; Device: CCL-VARIO UV lamp |
| 18 mW/cm2 | Active comparator | CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution Receives: Drug: Riboflavin 0.1% ophthalmic solution; Device: CCL-VARIO at 18 mW/cm2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in maximum corneal curvature
Measured: 3 and 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Mack, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Mack, M.D., Mack Eye Center
- Investigators
- Robert J Mack, M.D., Principal investigator, Mack Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009709
- Sponsor's protocol ID
- MEC-0001
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia
- ClinicalTrials.gov ID
- NCT02009709
- Acronym / sponsor ID
- MEC-0001
- Conditions
- Keratoconus, Corneal Ectasia
- Keywords
- keratoconus, collagen crosslinking, crosslinking, ectasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert Mack, M.D.University, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (estimated)
- First posted
- 12 Dec 2013 (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 primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9 mW/cm2 | Active comparator | Drug: Riboflavin 0.1% ophthalmic solution, Device: CCL-VARIO UV lampCCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution |
| 18 mW/cm2 | Active comparator | Drug: Riboflavin 0.1% ophthalmic solution, Device: CCL-VARIO at 18 mW/cm2CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Having a diagnosis of progressive keratoconus:
- An increase of ≥ 1.00 D in the steepest keratometry value
- An increase of ≥ 1.00 D in astigmatism manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Presence of central or inferior steepening on the Pentacam map.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Riboflavin 0.1% ophthalmic solutionAlso: CXL, CCL, crosslinkingInstillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure. | Drug | 18 mW/cm2, 9 mW/cm2 |
| CCL-VARIO UV lampAlso: CXL, CCL, crosslinkingApplication of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes | Device | 9 mW/cm2 |
| CCL-VARIO at 18 mW/cm2Also: CXL, CCL, crosslinkingApplication of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes. | Device | 18 mW/cm2 |
Primary outcome
Decrease in maximum corneal curvature
Time frame: 3 and 6 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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 J Mack, M.D. principal investigator
Mack Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Riboflavin 0.1% ophthalmic solution, CCL-VARIO UV lamp and CCL-VARIO at 18 mW/cm2 in people with Keratoconus and Corneal Ectasia, run by Robert Mack, M.D. 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 29 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert J Mack, M.D. (847-755-9393, rjsmack@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in maximum corneal curvature (time frame: 3 and 6 months post-procedure). 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 14 Dec 2015.