Progressive KeratoconusPhase 3NCT03442751
Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
A Phase 3 study testing Test Article A, Test Article B and KXL medical device system in people with Progressive Keratoconus, run by Glaukos Corporation at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- Test Article A, Test Article B and KXL medical device system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 10 Aug 2020
- Phase
- Phase 3
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between 12 and 55 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as having a parent or legal guardian sign an informed consent
- Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire;
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of each study eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- Having topographic and clinical evidence of keratoconus
Who cannot join
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
- If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
- A history of delayed epithelial healing in the eye to be treated or a current condition that may interfere with or prolong epithelial healing;
- A history of previous corneal cross-linking treatment in the eye to be treated;
- Have used an investigational drug or device within 30 days of screening or be concurrently enrolled in another investigational drug or device trial within 30 days of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Boston
Waltham, Massachusetts, 02451
About this study
Official title: A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus
To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.
Read the detailed description
Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change in Kmax from baseline to Month 6.
- Conditions
- Progressive Keratoconus
- Being tested
- Test Article A, Test Article B, Placebo, KXL medical device system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Article ADrug
Riboflavin Ophthalmic Solution A
Test Article BDrug
Riboflavin Ophthalmic Solution B
PlaceboDrug
Placebo Vehicle of Test Article
KXL medical device systemDevice
Mock UVA light source
KXL medical device systemDevice
Cross-linking UVA light source
| Study group | Role | What they receive |
|---|---|---|
| Epithelium-on CXL Treatment Group | Experimental | Study eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system Receives: Drug: Test Article A; Drug: Test Article B; Device: KXL medical device system |
| Sham Treatment/Control Group | Sham comparator | Sham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system Receives: Drug: Placebo; Device: KXL medical device system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Measured: 6 months
Secondary outcomes (1)
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax
Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax
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 posted22 Feb 2018
- Study start6 Apr 2018
- Primary completion1 Nov 2019
- Study completion10 Aug 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valerie Smith, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442751
- Sponsor's protocol ID
- ACP-KXL-308
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2018
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lombardo M, Serrao S, Mencucci R, Buzzi M, Alunni Fegatelli D, Vestri A, Lombardo G. One-year clinical outcomes of theranostic-guided transepithelial corneal UV therapy for progressive keratoconus. J Cataract Refract Surg. 2026 Sep 25. doi: 10.1097/j.jcrs.0000000000002040. Online ahead of print.
PubMed 42640621
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT03442751
- Acronym / sponsor ID
- ACP-KXL-308
- Conditions
- Progressive Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.
Detailed description
Up to 275 study eyes with progressive keratoconus will be enrolled. Study eyes will be randomized in a 2:1 ratio to receive CXL treatment or sham/control treatment.The primary efficacy endpoint is a difference of ≥ 1 diopter between treatment groups in the mean change in Kmax from baseline to Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham
| Arm | Type | Receives |
|---|---|---|
| Epithelium-on CXL Treatment Group | Experimental | Drug: Test Article A, Drug: Test Article B, Device: KXL medical device systemStudy eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system |
| Sham Treatment/Control Group | Sham comparator | Drug: Placebo, Device: KXL medical device systemSham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be between 12 and 55 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as having a parent or legal guardian sign an informed consent
- Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire;
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of each study eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
Key exclusion criteria (6 listed)
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
- If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
- A history of delayed epithelial healing in the eye to be treated or a current condition that may interfere with or prolong epithelial healing;
- A history of previous corneal cross-linking treatment in the eye to be treated;
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 |
|---|---|---|
| Test Article ARiboflavin Ophthalmic Solution A | Drug | Epithelium-on CXL Treatment Group |
| Test Article BRiboflavin Ophthalmic Solution B | Drug | Epithelium-on CXL Treatment Group |
| PlaceboPlacebo Vehicle of Test Article | Drug | Sham Treatment/Control Group |
| KXL medical device systemMock UVA light source | Device | Sham Treatment/Control Group |
| KXL medical device systemCross-linking UVA light source | Device | Epithelium-on CXL Treatment Group |
Primary outcome
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax
Time frame: 6 months
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
1 secondary outcome
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42640621Lombardo M, Serrao S, Mencucci R, Buzzi M, Alunni Fegatelli D, Vestri A, Lombardo G. One-year clinical outcomes of theranostic-guided transepithelial corneal UV therapy for progressive keratoconus. J Cataract Refract Surg. 2026 Sep 25. doi: 10.1097/j.jcrs.0000000000002040. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Progressive Keratoconus
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Study of TN-001 Topical Eyedrops 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.
Valerie Smith study director
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test Article A, Test Article B and KXL medical device system in people with Progressive Keratoconus, run by Glaukos Corporation 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 6 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: finished, as of the sponsor's last update on 30 Jan 2024. 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. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). 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?
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442751, which also lists 1 linked publication.
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 30 Jan 2024.