Trial Outcomes & Findings for Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure (NCT NCT04962009)
NCT ID: NCT04962009
Last Updated: 2023-09-13
Results Overview
Mean percent change in Intraocular Pressure (IOP) from baseline to days 90
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
day 90
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug
Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug: Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
|
|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure
Baseline characteristics by cohort
| Measure |
Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug
n=12 Participants
Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug: Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: day 90Mean percent change in Intraocular Pressure (IOP) from baseline to days 90
Outcome measures
| Measure |
Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug
n=10 Participants
Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug: Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
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|---|---|
|
Mean Percent Intraocular Pressure (IOP) Change
|
-14.6 mean % Intraocular Pressure (IOP) change
Interval -36.1 to 7.6
|
Adverse Events
Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Travoprost Evolute® (Travoprost Punctal Plug Delivery System, T-PPDS), 166 ug
n=12 participants at risk
Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug: Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.
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|---|---|
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Eye disorders
Foreign Body sensation, single/mild
|
8.3%
1/12 • Number of events 1 • AEs data was collected at all timepoints from baseline to 90 days (final visit)
AEs were collected by the investigator asking the patient "Have you had any problems since your last visit?" and collecting the response
|
|
Eye disorders
retinal migraine OS
|
8.3%
1/12 • Number of events 1 • AEs data was collected at all timepoints from baseline to 90 days (final visit)
AEs were collected by the investigator asking the patient "Have you had any problems since your last visit?" and collecting the response
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can not publish data without our permission. Sponsor can change communication and extend an embargo.
- Publication restrictions are in place
Restriction type: OTHER