Glaucoma
Conditions
Keywords
Glaucoma
Brief summary
The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.
Interventions
DEVICEEx-PRESS® Glaucoma Filtration Device, Model P50PL
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of normal tension glaucoma. * Indicated for filtration surgery using Ex-PRESS®. * Understand and provide Informed Consent. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women who are pregnant, lactating, or planning to be pregnant during the study period. * Diagnosis of angle closure glaucoma or secondary glaucoma. * History of glaucoma surgery. * Ophthalmologic surgery within the past 6 months. * Difficulty with applanation tonometry measurement. * Corneal dystrophy. * Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye. * Severe blepharitis or dry eye. * History of metal allergy. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) | Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis. |
| Change From Baseline in IOP | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis. |
| Percent Change From Baseline in IOP | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis. |
| Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 | Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis. |
| Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP | Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. |
| Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3, Month 6, Month 12 Post-Operative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 3 study centers located in Japan.
Participants by arm
| Arm | Count |
|---|---|
| Ex-PRESS Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Change of residence | 1 |
Baseline characteristics
| Characteristic | Ex-PRESS |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10.8 |
| Intraocular Pressure (IOP) | 14.8 mmHG STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 13 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Change From Baseline in IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat, with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ex-PRESS | Change From Baseline in IOP | Month 3 | -5.4 mmHG | Standard Deviation 4.6 |
| Ex-PRESS | Change From Baseline in IOP | Month 6 | -5.4 mmHG | Standard Deviation 4.8 |
| Ex-PRESS | Change From Baseline in IOP | Month 12 | -4.9 mmHG | Standard Deviation 4.2 |
Primary
Mean Intraocular Pressure (IOP)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Time frame: Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat, with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ex-PRESS | Mean Intraocular Pressure (IOP) | Month 3 | 9.4 mmHG | Standard Deviation 4.3 |
| Ex-PRESS | Mean Intraocular Pressure (IOP) | Month 6 | 9.5 mmHG | Standard Deviation 3.8 |
| Ex-PRESS | Mean Intraocular Pressure (IOP) | Month 12 | 10.0 mmHG | Standard Deviation 3.1 |
Primary
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.
Time frame: Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat Analysis Set with non-missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ex-PRESS | Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP | Month 3 | 0.0 percentage of eyes |
| Ex-PRESS | Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP | Month 6 | 0.0 percentage of eyes |
| Ex-PRESS | Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP | Month 12 | 3.2 percentage of eyes |
Primary
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.
Time frame: Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat, with non-missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ex-PRESS | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3 | 88 percentage of eyes |
| Ex-PRESS | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 12 | 100 percentage of eyes |
| Ex-PRESS | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 6 | 94 percentage of eyes |
| Ex-PRESS + Needling | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 6 | 3 percentage of eyes |
| Ex-PRESS + Needling | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3 | 12 percentage of eyes |
| Ex-PRESS + Needling | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 12 | 0 percentage of eyes |
| Ex-PRESS + Laser Suture Lysis | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 6 | 0 percentage of eyes |
| Ex-PRESS + Laser Suture Lysis | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3 | 0 percentage of eyes |
| Ex-PRESS + Laser Suture Lysis | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 12 | 0 percentage of eyes |
| Ex-PRESS + Conjunctival Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3 | 0 percentage of eyes |
| Ex-PRESS + Conjunctival Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 12 | 0 percentage of eyes |
| Ex-PRESS + Conjunctival Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 6 | 3 percentage of eyes |
| Ex-PRESS + Scleral Flap Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 6 | 3 percentage of eyes |
| Ex-PRESS + Scleral Flap Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 3 | 0 percentage of eyes |
| Ex-PRESS + Scleral Flap Suture | Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP | Month 12 | 0 percentage of eyes |
Primary
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat, with non-missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ex-PRESS | Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 | Month 6 | 82.1 percentage of eyes |
| Ex-PRESS | Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 | Month 3 | 72.4 percentage of eyes |
| Ex-PRESS | Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 | Month 12 | 61.5 percentage of eyes |
Primary
Percent Change From Baseline in IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Population: Intent-to-Treat, with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ex-PRESS | Percent Change From Baseline in IOP | Month 3 | -35.4 percent change | Standard Deviation 30.1 |
| Ex-PRESS | Percent Change From Baseline in IOP | Month 6 | -33.7 percent change | Standard Deviation 33.5 |
| Ex-PRESS | Percent Change From Baseline in IOP | Month 12 | -31.1 percent change | Standard Deviation 23.6 |