KeratoconusPhase 2NCT02762253
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.
A Phase 2 study testing Riboflavin drops in people with Keratoconus, run by Nvision Laser Eye Centers at 11 sites in United States.
Trial summary
This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Riboflavin drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2012to Apr 2016
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact lens removal prior to evaluation and treatment
- Candidates must also have two of the following criteria:
- Presence of central or inferior steepening on the Pentacam or Orbscan map consistent with Keratoconus.
Show all 16Show fewer
- Axial topography consistent with keratoconus.
- Steepest keratometry (Kmax) value of 47.00D
- History of having undergone a keratorefractive procedure and 2 of the following criteria:
- Steepening by topography, either Pentacam or Orbscan
- 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 BSCVA
Who cannot join
- Eyes classified as either normal or atypical normal 2. Corneal pachymetry 350 microns at the thinnest point measured by Pentacam in the eye to be treated 3. A history of chemical injury or delayed epithelial healing in the eye to be treated.
- 4. Pregnancy (including plan to become pregnant) or lactation during the course of the study 5. A known sensitivity to study medications 6. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment 7. Inability to cooperate with diagnostic tests. 8. Patients with a concomitant condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- 9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- 10. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.
- -
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Teplick Custom Vision
Beaverton, Oregon, 97008
NVISION Camarillo
Camarillo, California, 93010
NVISION Sacramento
Citrus Heights, California, 95621
NVISION Fullerton
Fullerton, California, 92831
NVISION Laguna Hills
Laguna Hills, California, 92653
NVISION Las Vegas
Las Vegas, Nevada, 89119
NVISION Newport Beach
Newport Beach, California, 92660
NVISION Ontario
Ontario, California, 91764
NVISION La Jolla
San Diego, California, 92122
Berg Feinfield Vision Center
Sherman Oaks, California, 91423
NVISION Torrance
Torrance, California, 90505
About this study
Official title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irrandiance of 18 mW/cm2 in Eyes With Keratoconus or Ectasia.
This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.
Read the detailed description
Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.
- Conditions
- Keratoconus
- Being tested
- Riboflavin drops
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin dropsDrug
Also called Rincolin
Riboflavin drops were used every 2 minutes for 30 minutes on the cornea then exposed to 5 minutes of Ultraviolet light at an intensity of 18mW/cm2
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin drops - epithelium on or off | Other | Riboflavin is applied with Epithelium on or with it off. 6 months follow up to find out magnitude of Decrease in Kmax Receives: Drug: Riboflavin drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratometry
The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months for all eyes. Data will be summarized using descriptive statistics.
Measured: 6 months
Secondary outcomes (3)
manifest refraction
The change in manifest refraction at 6 months compared to pre op
Measured: 6 months
Visual Acuity
Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.
Measured: 6 months
Central Pachymetry
The change in central pachymetry (as measured by Pentacam) from baseline will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startSep 2012
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: No IND submitted to the FDA
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nvision Laser Eye Centers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- tom s tooma, md, Principal investigator, NVISION Eye Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762253
- Sponsor's protocol ID
- NV001
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. 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 Irrandiance of 18 mW/cm2 in Eyes With Keratoconus or Ectasia.
- ClinicalTrials.gov ID
- NCT02762253
- Acronym / sponsor ID
- NV001
- Conditions
- Keratoconus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No IND submitted to the FDA
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Nvision Laser Eye CentersIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 May 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.
This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.
Detailed description
Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Riboflavin drops - epithelium on or off | Other | Drug: Riboflavin dropsRiboflavin is applied with Epithelium on or with it off. 6 months follow up to find out magnitude of Decrease in Kmax |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 12 years of age or older
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact lens removal prior to evaluation and treatment
- Candidates must also have two of the following criteria:
Key exclusion criteria (5 listed)
- 4. Pregnancy (including plan to become pregnant) or lactation during the course of the study 5. A known sensitivity to study medications 6. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment 7. Inability to cooperate with diagnostic tests. 8. Patients with a concomitant condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- 9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- 10. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.
- -
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 dropsAlso: RincolinRiboflavin drops were used every 2 minutes for 30 minutes on the cornea then exposed to 5 minutes of Ultraviolet light at an intensity of 18mW/cm2 | Drug | Riboflavin drops - epithelium on or off |
Primary outcome
Keratometry
Time frame: 6 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months for all eyes. Data will be summarized using descriptive statistics.
3 secondary outcomes
manifest refraction
Time frame: 6 months
Visual Acuity
Time frame: 6 months
Central Pachymetry
Time frame: 6 months
Results and safety
The study was stopped early (reason given: No IND submitted to the FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
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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.
tom s tooma, md principal investigator
NVISION Eye Centers
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riboflavin drops in people with Keratoconus, run by Nvision Laser Eye Centers at 11 sites 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 16 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: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No IND submitted to the FDA). Results are not available in the source record.
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?
Keratometry (time frame: 6 months). 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 5 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.