Trial Outcomes & Findings for Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution (NCT NCT02754596)
NCT ID: NCT02754596
Last Updated: 2023-09-26
Results Overview
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-26
Participant Flow
Subjects underwent a washout from IOP-lowering medications after enrollment and prior to assignment to groups
Participant milestones
| Measure |
Travoprost Intraocular Implant, High Elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
54
|
49
|
|
Overall Study
Month 3
|
51
|
54
|
49
|
|
Overall Study
COMPLETED
|
44
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
4
|
Reasons for withdrawal
| Measure |
Travoprost Intraocular Implant, High Elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Death
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
Baseline characteristics by cohort
| Measure |
Travoprost Intraocular Implant, High Elution
n=51 Participants
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
n=54 Participants
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
n=49 Participants
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
Total
n=154 Participants
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
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
119 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Baseline IOP
|
26.4 mmHg
STANDARD_DEVIATION 4.9 • n=5 Participants
|
25.3 mmHg
STANDARD_DEVIATION 4.7 • n=7 Participants
|
25.3 mmHg
STANDARD_DEVIATION 3.9 • n=5 Participants
|
25.7 mmHg
STANDARD_DEVIATION 4.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: intent-to-treat population
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Outcome measures
| Measure |
Travoprost Intraocular Implant, High Elution
n=51 Participants
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
n=54 eyes
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
n=49 eyes
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
IOP (mmHg) Change From Baseline at Week 12
|
-8.3 mmHg
Standard Error 0.34
|
-7.7 mmHg
Standard Error 0.26
|
-7.5 mmHg
Standard Error 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-op through Month 36Population: study eyes
The number and percent of subjects with severe adverse events in the study eye
Outcome measures
| Measure |
Travoprost Intraocular Implant, High Elution
n=51 Participants
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
n=54 Participants
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
n=49 Participants
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
Severe Adverse Events
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Travoprost Intraocular Implant, High Elution
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Travoprost Intraocular Implant, Low Elution
Serious events: 9 serious events
Other events: 22 other events
Deaths: 2 deaths
Timolol Maleate Ophthalmic Solution, 0.5%
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Travoprost Intraocular Implant, High Elution
n=51 participants at risk
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
n=54 participants at risk
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
n=49 participants at risk
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Cardiac disorders
cardiac arrest
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Cardiac disorders
cardiac disorders
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Cardiac disorders
coronary artery disease
|
0.00%
0/51 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
General disorders
death
|
0.00%
0/51 • overall study period of 36 months
|
3.7%
2/54 • Number of events 2 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Infections and infestations
pneumonia
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Infections and infestations
sepsis
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Infections and infestations
septic shock
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Nervous system disorders
cerebral infarction
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Nervous system disorders
myasthenia gravis
|
0.00%
0/51 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/51 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hepatic cancer
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Vascular disorders
haematoma
|
0.00%
0/51 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
Other adverse events
| Measure |
Travoprost Intraocular Implant, High Elution
n=51 participants at risk
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, high elution: Surgical implant placed within the eye to elute travoprost.
|
Travoprost Intraocular Implant, Low Elution
n=54 participants at risk
This implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution: Surgical implant placed within the eye to elute travoprost
|
Timolol Maleate Ophthalmic Solution, 0.5%
n=49 participants at risk
Timolol, a beta blocker, will be dosed twice daily
Timolol Maleate Ophthalmic Solution, 0.5%: Instillation of one drop of timolol in the study eye twice daily
|
|---|---|---|---|
|
Eye disorders
cataract
|
7.8%
4/51 • Number of events 4 • overall study period of 36 months
|
5.6%
3/54 • Number of events 3 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Eye disorders
visual acuity reduced
|
5.9%
3/51 • Number of events 3 • overall study period of 36 months
|
7.4%
4/54 • Number of events 4 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Eye disorders
vitreous detachment
|
3.9%
2/51 • Number of events 2 • overall study period of 36 months
|
5.6%
3/54 • Number of events 3 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Eye disorders
blepharitis
|
5.9%
3/51 • Number of events 3 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Eye disorders
conjunctival hemorrhage
|
3.9%
2/51 • Number of events 2 • overall study period of 36 months
|
5.6%
3/54 • Number of events 3 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Eye disorders
eye pain
|
5.9%
3/51 • Number of events 3 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Eye disorders
foreign body sensation in eyes
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
5.6%
3/54 • Number of events 3 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Eye disorders
eye inflammation
|
5.9%
3/51 • Number of events 3 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Infections and infestations
bronchitis
|
2.0%
1/51 • Number of events 1 • overall study period of 36 months
|
1.9%
1/54 • Number of events 1 • overall study period of 36 months
|
6.1%
3/49 • Number of events 3 • overall study period of 36 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.8%
4/51 • Number of events 4 • overall study period of 36 months
|
3.7%
2/54 • Number of events 2 • overall study period of 36 months
|
0.00%
0/49 • overall study period of 36 months
|
|
Investigations
intraocular pressure increased
|
3.9%
2/51 • Number of events 2 • overall study period of 36 months
|
3.7%
2/54 • Number of events 2 • overall study period of 36 months
|
10.2%
5/49 • Number of events 5 • overall study period of 36 months
|
|
Vascular disorders
hypertension
|
3.9%
2/51 • Number of events 2 • overall study period of 36 months
|
7.4%
4/54 • Number of events 4 • overall study period of 36 months
|
2.0%
1/49 • Number of events 1 • overall study period of 36 months
|
|
Immune system disorders
drug hypersensitivity
|
3.9%
2/51 • Number of events 2 • overall study period of 36 months
|
0.00%
0/54 • overall study period of 36 months
|
6.1%
3/49 • Number of events 3 • overall study period of 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of data from this study.
- Publication restrictions are in place
Restriction type: OTHER