Progressive KeratoconusPhase 1/2NCT05314738
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
A Phase 1/2 study testing NXL Energy 1, NXL Energy 2 and NXL Energy 3 in people with Progressive Keratoconus, run by Glaukos Corporation at 3 sites in United States.
Trial summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- NXL Energy 1, NXL Energy 2 and NXL Energy 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2022to Feb 2026
- Phase
- Phase 1/2
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent
- Ability to hold gaze sufficiently stable for study testing
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- Have a diagnosis of keratoconus
Who cannot join
- Known allergy or sensitivity to the test articles or components
- Any disease causing abnormal topography other than keratoconus
- Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Glaukos Investigative Site
Dothan, Alabama, 36301
- Recruiting
Glaukos Investigative Site
Teaneck, New Jersey, 07666
- Recruiting
Glaukos Investigative Site
Westerville, Ohio, 43082
About this study
Official title: A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Read the detailed description
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.
- Conditions
- Progressive Keratoconus
- Being tested
- NXL Energy 1, NXL Energy 2, NXL Energy 3, Sham Treatment
- Keywords
- Eye rubbing, Collagen cross-linking, Keratoconus, Progressive Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXL Energy 1Combination product
Riboflavin drops + NXL System to Total Energy Level 1
NXL Energy 2Combination product
Riboflavin drops + NXL System to Total Energy Level 2
NXL Energy 3Combination product
Riboflavin drops + NXL System to Total Energy Level 3
Sham TreatmentCombination product
Sham Drops and No exposure to NXL system
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1 | Experimental | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 Receives: Combination Product: NXL Energy 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 Receives: Combination Product: NXL Energy 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 Receives: Combination Product: NXL Energy 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 Receives: Combination Product: NXL Energy 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 Receives: Combination Product: NXL Energy 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 Receives: Combination Product: NXL Energy 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B | Active comparator | Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 Receives: Combination Product: NXL Energy 3 |
| Placebo Group 2 / Cohort 2B | Sham comparator | Sham Solution with no exposure to NXL System Receives: Combination Product: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topography
Change in Kmax topography value from baseline
Measured: 12 Months
Secondary outcomes (1)
Distance Uncorrected Visual Acuity (UCVA)
Change in Distance UCVA
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start8 Mar 2022
- Primary completionAug 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive KeratoconusStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314738
- Sponsor's protocol ID
- NXL-101-KCON
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
- ClinicalTrials.gov ID
- NCT05314738
- Acronym / sponsor ID
- NXL-101-KCON
- Conditions
- Progressive Keratoconus
- Keywords
- Eye rubbing, Collagen cross-linking, Keratoconus, Progressive Keratoconus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Apr 2022 (actual)
- 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.
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Detailed description
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1 | Experimental | Combination Product: NXL Energy 3Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A | Active comparator | Combination Product: NXL Energy 1Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A | Active comparator | Combination Product: NXL Energy 2Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A | Active comparator | Combination Product: NXL Energy 3Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B | Active comparator | Combination Product: NXL Energy 1Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B | Active comparator | Combination Product: NXL Energy 2Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 |
| Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B | Active comparator | Combination Product: NXL Energy 3Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 |
| Placebo Group 2 / Cohort 2B | Sham comparator | Combination Product: Sham TreatmentSham Solution with no exposure to NXL System |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provide written informed consent
- Ability to hold gaze sufficiently stable for study testing
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- Have a diagnosis of keratoconus
Key exclusion criteria (3 listed)
- Known allergy or sensitivity to the test articles or components
- Any disease causing abnormal topography other than keratoconus
- Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
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 |
|---|---|---|
| NXL Energy 1Riboflavin drops + NXL System to Total Energy Level 1 | Combination product | Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B |
| NXL Energy 2Riboflavin drops + NXL System to Total Energy Level 2 | Combination product | Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B |
| NXL Energy 3Riboflavin drops + NXL System to Total Energy Level 3 | Combination product | Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B |
| Sham TreatmentSham Drops and No exposure to NXL system | Combination product | Placebo Group 2 / Cohort 2B |
Primary outcome
Topography
Time frame: 12 Months
Change in Kmax topography value from baseline
1 secondary outcome
Distance Uncorrected Visual Acuity (UCVA)
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Progressive Keratoconus
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
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Enrolling by invitationPhase 1/2
Study of TN-001 Topical Eyedrops for Keratoconus
Keratoconus
RecruitingPhase 3
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Progressive Keratoconus
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NXL Energy 1, NXL Energy 2 and NXL Energy 3 in people with Progressive Keratoconus, run by Glaukos Corporation at 3 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 4 inclusion and 3 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Armijo (562-761-7965, marmijo@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topography (time frame: 12 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 8 Jul 2024.