Trial Outcomes & Findings for Safety Study of the VEGA UV-A System to Treat Keratoconus (NCT NCT01190306)

NCT ID: NCT01190306

Last Updated: 2022-07-12

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

127 participants

Primary outcome timeframe

6 Months

Results posted on

2022-07-12

Participant Flow

Patients were recruited from August, 2010 to December 2011 from medical clinics throughout the country.

Patients that were excluded from the clinical trial were considered screen failures due to not meeting one or more of the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	CXL Treatment Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.	Sham Control Eyes in the control group will be treated with riboflavin only.
Overall Study STARTED	61	66
Overall Study COMPLETED	61	66
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 Keratoconus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CXL Treatment n=61 Participants Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.	Sham Control n=66 Participants Eyes in the control group will be treated with riboflavin only.	Total n=127 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	NA participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, 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

Robert 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