Trial Outcomes & Findings for Performance of the Travoprost Intraocular Implant (NCT NCT06582732)
NCT ID: NCT06582732
Last Updated: 2024-10-15
Results Overview
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
month 12
Results posted on
2024-10-15
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Cohort 1 (12-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
Cohort 2 (3-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
|
Cohort 3 (6-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
|
Cohort 4 (24-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 24
Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
|
Cohort 5 (21-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 21
Travoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
|
Cohort 6 (18-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 18
Travoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
|
Cohort 7 (15-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 15
Travoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
|
|---|---|---|---|---|---|---|---|
|
Initial Study Period
STARTED
|
30 30
|
30 30
|
30 30
|
30 30
|
30 30
|
30 30
|
30 30
|
|
Initial Study Period
COMPLETED
|
29 29
|
29 29
|
28 28
|
27 27
|
25 25
|
29 29
|
28 28
|
|
Initial Study Period
NOT COMPLETED
|
1 1
|
1 1
|
2 2
|
3 3
|
5 5
|
1 1
|
2 2
|
|
Post-exchange Study Period
STARTED
|
29 29
|
29 29
|
28 28
|
27 27
|
25 25
|
29 29
|
28 28
|
|
Post-exchange Study Period
COMPLETED
|
29 29
|
29 29
|
28 28
|
27 27
|
25 25
|
29 29
|
28 28
|
|
Post-exchange Study Period
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Cohort 1 (12-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
Cohort 2 (3-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
|
Cohort 3 (6-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
|
Cohort 4 (24-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 24
Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
|
Cohort 5 (21-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 21
Travoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
|
Cohort 6 (18-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 18
Travoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
|
Cohort 7 (15-month Exchange)
Travoprost Intracameral Implant Exchanged at Month 15
Travoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
|
|---|---|---|---|---|---|---|---|
|
Initial Study Period
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Initial Study Period
Death
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Initial Study Period
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Initial Study Period
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
3
|
1
|
2
|
|
Initial Study Period
Moved Away
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Performance of the Travoprost Intraocular Implant
Baseline characteristics by cohort
| Measure |
Cohort 1 (12-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
Cohort 2 (3-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
|
Cohort 3 (6-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
|
Cohort 4 (24-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 24
Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
|
Cohort 5 (21-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 21
Travoprost intracameral implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
|
Cohort 6 (18-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 18
Travoprost intracameral implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
|
Cohort 7 (15-month Exchange)
n=30 study eyes
Travoprost Intracameral Implant Exchanged at Month 15
Travoprost intracameral implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
|
Total
n=210 study eyes
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
103 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
107 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
103 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
107 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
210 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Armenia
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
30 participants
n=10 Participants
|
30 participants
n=115 Participants
|
210 participants
n=24 Participants
|
|
Type of Disease
Open-angle glaucoma
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
210 Participants
n=24 Participants
|
|
Type of Disease
Ocular hypertension
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: month 12Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=29 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
|
5.57 ng/mL
Standard Deviation 3.02
|
PRIMARY outcome
Timeframe: month 3Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=27 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
|
4.98 ng/mL
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: month 6Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=25 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
|
3.74 ng/mL
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: month 24Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=25 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
|
3.35 ng/mL
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: month 21Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=27 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
|
3.80 ng/mL
Standard Deviation 1.58
|
PRIMARY outcome
Timeframe: month 18Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=29 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
|
2.22 ng/mL
Standard Deviation 1.24
|
PRIMARY outcome
Timeframe: month 15Population: study eyes
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=28 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
|
2.03 ng/mL
Standard Deviation 0.736
|
SECONDARY outcome
Timeframe: month 12Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=29 eyes
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
|
50.2 percentage of initial
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: month 3Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=29 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration
|
78.8 percentage of initial
Standard Error 3.15
|
SECONDARY outcome
Timeframe: month 6Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=28 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration
|
69.8 percentage of initial
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: month 24Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=25 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration
|
16.3 percentage of initial
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: month 21Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=27 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration
|
28.0 percentage of initial
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: month 18Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=29 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration
|
34.8 percentage of initial
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: month 15Population: explanted travoprost intracameral implants
percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC
Outcome measures
| Measure |
Cohort 1 (12-month Exchange)
n=28 explanted implants
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
|---|---|
|
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration
|
38.6 percentage of initial
Standard Deviation 8.23
|
Adverse Events
Cohort 1 (12-month Exchange)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 2 (3-month Exchange)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3 (6-month Exchange)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4 (24-month Exchange)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 (21-month Exchange)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort 6 (18-month Exchange)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 7 (15-month Exchange)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (12-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
Cohort 2 (3-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
|
Cohort 3 (6-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
|
Cohort 4 (24-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 24
Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
|
Cohort 5 (21-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 21
Travoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
|
Cohort 6 (18-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 18
Travoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
|
Cohort 7 (15-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 15
Travoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
Other adverse events
| Measure |
Cohort 1 (12-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
|
Cohort 2 (3-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
|
Cohort 3 (6-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
|
Cohort 4 (24-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 24
Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
|
Cohort 5 (21-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 21
Travoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
|
Cohort 6 (18-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 18
Travoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
|
Cohort 7 (15-month Exchange)
n=30 participants at risk
Travoprost Intracameral Implant Exchanged at Month 15
Travoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Corona virus infection
|
6.7%
2/30 • Number of events 2 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
10.0%
3/30 • Number of events 3 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
|
Eye disorders
Iridodialysis
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
|
Investigations
Intraocular pressure increased
|
6.7%
2/30 • Number of events 3 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
6.7%
2/30 • Number of events 2 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
3.3%
1/30 • Number of events 1 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
0.00%
0/30 • initial travoprost intracameral implant period plus 4 weeks post-exchange
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place