Glaucoma Open-angle
Conditions
Brief summary
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.
Detailed description
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.
Interventions
DRUGTravoprost Intraocular Implant, high elution
Surgical implant placed within the eye to elute travoprost.
DRUGTravoprost Intraocular Implant, low elution
Surgical implant placed within the eye to elute travoprost
Instillation of one drop of timolol in the study eye twice daily
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open angle glaucoma
Exclusion criteria
* Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders. * Functionally significant visual field loss, including severe nerve fiber bundle defects. * Prior glaucoma surgery. * Uncontrolled systemic disease, pregnant females or those planning a pregnancy. * Other ocular status conditions, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP (mmHg) Change From Baseline at Week 12 | 12 weeks | Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severe Adverse Events | Post-op through Month 36 | The number and percent of subjects with severe adverse events in the study eye |
Countries
United States
Participant flow
Pre-assignment details
Subjects underwent a washout from IOP-lowering medications after enrollment and prior to assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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 | 54 |
| 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 | 49 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Death | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 0 |
Baseline characteristics
| Characteristic | Travoprost Intraocular Implant, High Elution | Travoprost Intraocular Implant, Low Elution | Timolol Maleate Ophthalmic Solution, 0.5% | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 24 Participants | 25 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 30 Participants | 24 Participants | 82 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 9.8 | 61.4 years STANDARD_DEVIATION 13.9 | 63.0 years STANDARD_DEVIATION 12.6 | 62.7 years STANDARD_DEVIATION 12.2 |
| Baseline IOP | 26.4 mmHg STANDARD_DEVIATION 4.9 | 25.3 mmHg STANDARD_DEVIATION 4.7 | 25.3 mmHg STANDARD_DEVIATION 3.9 | 25.7 mmHg STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 53 Participants | 46 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 5 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 41 Participants | 41 Participants | 37 Participants | 119 Participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 20 Participants | 76 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 29 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 2 / 54 | 0 / 49 |
| other Total, other adverse events | 28 / 51 | 22 / 54 | 14 / 49 |
| serious Total, serious adverse events | 4 / 51 | 9 / 54 | 3 / 49 |
Outcome results
Primary
IOP (mmHg) Change From Baseline at Week 12
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Time frame: 12 weeks
Population: intent-to-treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travoprost Intraocular Implant, High Elution | IOP (mmHg) Change From Baseline at Week 12 | -8.3 mmHg | Standard Error 0.34 |
| Travoprost Intraocular Implant, Low Elution | IOP (mmHg) Change From Baseline at Week 12 | -7.7 mmHg | Standard Error 0.26 |
| Timolol Maleate Ophthalmic Solution, 0.5% | IOP (mmHg) Change From Baseline at Week 12 | -7.5 mmHg | Standard Error 0.21 |
Other Pre-specified
Severe Adverse Events
The number and percent of subjects with severe adverse events in the study eye
Time frame: Post-op through Month 36
Population: study eyes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Travoprost Intraocular Implant, High Elution | Severe Adverse Events | 2 Participants |
| Travoprost Intraocular Implant, Low Elution | Severe Adverse Events | 2 Participants |
| Timolol Maleate Ophthalmic Solution, 0.5% | Severe Adverse Events | 2 Participants |