Trial Outcomes & Findings for Safety Study of the VEGA UV-A System to Treat Ectasia (NCT NCT01398839)

NCT ID: NCT01398839

Last Updated: 2022-06-29

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

103 participants

Primary outcome timeframe

6 Months

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 VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light Riboflavin : Both treatment and sham groups will receive riboflavin	Sham Control Riboflavin : Both treatment and sham groups will receive riboflavin
Overall Study STARTED	35	37
Overall Study COMPLETED	35	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of the VEGA UV-A System to Treat Ectasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CXL Treatment n=35 Participants VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light Riboflavin : Both treatment and sham groups will receive riboflavin	Sham Control n=37 Participants Riboflavin : Both treatment and sham groups will receive riboflavin	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Categorical >=65 years	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	37 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: The CXL-002 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

Sham Control

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