Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months
Interventions
DRUGTravoprost Intracameral Implant exchanged at Month 12
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
DRUGTravoprost Intracameral Implant exchanged at Month 3
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
DRUGTravoprost Intracameral Implant exchanged at Month 6
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
DRUGTravoprost Intracameral Implant exchanged at Month 24
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
DRUGTravoprost intracameral implant exchanged at Month 21
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
DRUGTravoprost intracameral implant exchanged at Month 18
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
DRUGTravoprost intracameral implant exchanged at Month 15
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15
Sponsors
Glaukos Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson * Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam. * Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye. * Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
Exclusion criteria
* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders * Active ocular inflammation, infection or edema * Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration | month 15 | concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration | month 12 | 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) |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration | month 3 | concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration | month 6 | concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration | month 24 | concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS |
| Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration | month 21 | concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS |
| Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration | month 18 | concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Residual Travoprost in Explanted Implant 12 Months Post-administration | month 12 | percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC) |
| Percent Residual Travoprost in Explanted Implant 3 Months Post-administration | month 3 | percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC |
| Percent Residual Travoprost in Explanted Implant 6 Months Post-administration | month 6 | percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC |
| Percent Residual Travoprost in Explanted Implant 24 Months Post-administration | month 24 | percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC |
| Percent Residual Travoprost in Explanted Implant 21 Months Post-administration | month 21 | percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC |
| Percent Residual Travoprost in Explanted Implant 18 Months Post-administration | month 18 | percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC |
| Percent Residual Travoprost in Explanted Implant 15 Months Post-administration | month 15 | percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC |
Countries
Armenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| 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 | 30 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| 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 | Moved Away | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Initial Study Period | Withdrawal by Subject | 0 | 1 | 0 | 1 | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Cohort 2 (3-month Exchange) | Cohort 3 (6-month Exchange) | Cohort 4 (24-month Exchange) | Cohort 5 (21-month Exchange) | Cohort 1 (12-month Exchange) | Cohort 6 (18-month Exchange) | Cohort 7 (15-month Exchange) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 14 Participants | 16 Participants | 13 Participants | 14 Participants | 18 Participants | 107 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 16 Participants | 14 Participants | 17 Participants | 16 Participants | 12 Participants | 103 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 210 Participants |
| Region of Enrollment Armenia | 30 participants | 30 participants | 30 participants | 30 participants | 30 participants | 30 participants | 30 participants | 210 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 15 Participants | 10 Participants | 15 Participants | 17 Participants | 16 Participants | 103 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 15 Participants | 20 Participants | 15 Participants | 13 Participants | 14 Participants | 107 Participants |
| Type of Disease Ocular hypertension | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Type of Disease Open-angle glaucoma | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 1 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 4 / 30 | 0 / 30 | 5 / 30 | 3 / 30 | 0 / 30 | 1 / 30 | 1 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 1 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
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)
Time frame: month 12
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration | 5.57 ng/mL | Standard Deviation 3.02 |
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
Time frame: month 15
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration | 2.03 ng/mL | Standard Deviation 0.736 |
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Time frame: month 18
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration | 2.22 ng/mL | Standard Deviation 1.24 |
Primary
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Time frame: month 21
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration | 3.80 ng/mL | Standard Deviation 1.58 |
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Time frame: month 24
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration | 3.35 ng/mL | Standard Deviation 1.51 |
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Time frame: month 3
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration | 4.98 ng/mL | Standard Deviation 2.5 |
Primary
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Time frame: month 6
Population: study eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration | 3.74 ng/mL | Standard Deviation 2.22 |
Secondary
Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)
Time frame: month 12
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 12 Months Post-administration | 50.2 percentage of initial | Standard Deviation 6.58 |
Secondary
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration
percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC
Time frame: month 15
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 15 Months Post-administration | 38.6 percentage of initial | Standard Deviation 8.23 |
Secondary
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration
percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC
Time frame: month 18
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 18 Months Post-administration | 34.8 percentage of initial | Standard Deviation 7.09 |
Secondary
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration
percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC
Time frame: month 21
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 21 Months Post-administration | 28.0 percentage of initial | Standard Deviation 5.76 |
Secondary
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration
percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC
Time frame: month 24
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 24 Months Post-administration | 16.3 percentage of initial | Standard Deviation 7.88 |
Secondary
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration
percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC
Time frame: month 3
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 3 Months Post-administration | 78.8 percentage of initial | Standard Error 3.15 |
Secondary
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration
percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC
Time frame: month 6
Population: explanted travoprost intracameral implants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (12-month Exchange) | Percent Residual Travoprost in Explanted Implant 6 Months Post-administration | 69.8 percentage of initial | Standard Deviation 8.51 |