Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Conditions

• Progressive Keratoconus

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• NXL Energy 1 — COMBINATION_PRODUCT
  Riboflavin drops + NXL System to Total Energy Level 1
• NXL Energy 2 — COMBINATION_PRODUCT
  Riboflavin drops + NXL System to Total Energy Level 2
• NXL Energy 3 — COMBINATION_PRODUCT
  Riboflavin drops + NXL System to Total Energy Level 3
• Sham Treatment — COMBINATION_PRODUCT
  Sham Drops and No exposure to NXL system

Study Details

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

Key Dates

Start date

Mar 8, 2022

Status verified

Jul 2024

Primary completion

Aug 31, 2025

Completion

Feb 28, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
• Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
  Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
• Sham Comparator: Placebo Group 2 / Cohort 2B
  Sham Solution with no exposure to NXL System

Primary Outcome Measure

Topography [ Time Frame: 12 Months ]

Central Contacts

• Marco Armijo
  562-761-7965
  [email protected]

Locations (3)

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