A Phase 1/2 interventional study of NXL Energy 1 and NXL Energy 2 in Progressive Keratoconus, sponsored by Glaukos Corporation. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Glaukos Corporation · Phase 1/2, Interventional, and Treatment
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Combination Product: NXL Energy 3
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Combination Product: NXL Energy 1
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Combination Product: NXL Energy 2
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Combination Product: NXL Energy 3
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Combination Product: NXL Energy 1
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Combination Product: NXL Energy 2
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Combination Product: NXL Energy 3
Sham Solution with no exposure to NXL System
Combination Product: Sham Treatment
Riboflavin drops + NXL System to Total Energy Level 1
Riboflavin drops + NXL System to Total Energy Level 2
Riboflavin drops + NXL System to Total Energy Level 3
Sham Drops and No exposure to NXL system
Topography
Change in Kmax topography value from baseline
Time frame: 12 Months
Distance Uncorrected Visual Acuity (UCVA)
Change in Distance UCVA
Time frame: 12 Months
Plan to share: No
No publications or documents are linked to this record.
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