Trial Outcomes & Findings for Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia (NCT NCT01398852)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

500 participants

Primary outcome timeframe

24 MO

Results posted on

2022-06-29

Participant Flow

The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.

Enrolled participants were excluded from the clinical trial because they failed to meet one or more the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	CXL Treatment All eyes to be treated with riboflavin and UV light
Overall Study STARTED	372
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	372

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CXL Treatment n=372 Participants All eyes to be treated with riboflavin and UV light
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	372 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 MO

Population: The CXL-003 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.

Outcome measures

Outcome data not reported

Adverse Events

CXL Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bob Gibson

Topcon Medical Systems

Phone: (201) 599-5121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All such Confidential Information shall remain the property of Topcon, as applicable, and Institution agrees that neither it nor Principal Investigator nor any of its employees or Sub-Investigators, if any, shall disclose any of the Confidential Information to third parties, without the prior written consent of Topcon.
Publication restrictions are in place

Restriction type: OTHER