Trial Outcomes & Findings for Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients (NCT NCT02246777)
NCT ID: NCT02246777
Last Updated: 2018-07-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Month 3, Month 6, Month 12 Post-Operative
Results posted on
2018-07-20
Participant Flow
Subjects were recruited from 3 study centers located in Japan.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Change of residence
|
1
|
Baseline Characteristics
This analysis population includes all subjects treated with the investigational device, whose test/assessment data after the use of the device were available, having no inclusion/exclusion criteria violation substantially affecting the efficacy evaluation (Intent-to-Treat Analysis Set).
Baseline characteristics by cohort
| Measure |
Ex-PRESS
n=32 Participants
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
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.8 • n=32 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=32 Participants
|
|
Intraocular Pressure (IOP)
|
14.8 mmHG
STANDARD_DEVIATION 2.3 • n=29 Participants • This analysis population includes all subjects treated with the investigational device, whose test/assessment data after the use of the device were available, having no inclusion/exclusion criteria violation substantially affecting the efficacy evaluation (Intent-to-Treat Analysis Set).
|
PRIMARY outcome
Timeframe: Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat, with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=29 Eyes
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
|
Ex-PRESS + Needling
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Mean Intraocular Pressure (IOP)
Month 3
|
9.4 mmHG
Standard Deviation 4.3
|
—
|
—
|
—
|
—
|
|
Mean Intraocular Pressure (IOP)
Month 6
|
9.5 mmHG
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
|
Mean Intraocular Pressure (IOP)
Month 12
|
10.0 mmHG
Standard Deviation 3.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat, with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=29 Eyes
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
|
Ex-PRESS + Needling
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Change From Baseline in IOP
Month 12
|
-4.9 mmHG
Standard Deviation 4.2
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IOP
Month 3
|
-5.4 mmHG
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IOP
Month 6
|
-5.4 mmHG
Standard Deviation 4.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat, with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=29 Eyes
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
|
Ex-PRESS + Needling
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in IOP
Month 3
|
-35.4 percent change
Standard Deviation 30.1
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in IOP
Month 6
|
-33.7 percent change
Standard Deviation 33.5
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in IOP
Month 12
|
-31.1 percent change
Standard Deviation 23.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat, with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=29 Eyes
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
|
Ex-PRESS + Needling
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
Month 3
|
72.4 percentage of eyes
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
Month 6
|
82.1 percentage of eyes
|
—
|
—
|
—
|
—
|
|
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 outcome
Timeframe: Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat Analysis Set with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=34 Eyes
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
|
Ex-PRESS + Needling
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
Month 3
|
0.0 percentage of eyes
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
Month 6
|
0.0 percentage of eyes
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
Month 12
|
3.2 percentage of eyes
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3, Month 6, Month 12 Post-OperativePopulation: Intent-to-Treat, with non-missing data
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.
Outcome measures
| Measure |
Ex-PRESS
n=34 Eyes
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
|
Ex-PRESS + Needling
n=34 Eyes
Ex-PRESS® Glaucoma Filtration Device with needling as a secondary surgical treatment
|
Ex-PRESS + Laser Suture Lysis
n=34 Eyes
Ex-PRESS® Glaucoma Filtration Device with laser suture lysis as a secondary surgical treatment
|
Ex-PRESS + Conjunctival Suture
n=34 Eyes
Ex-PRESS® Glaucoma Filtration Device with conjunctival suture as a secondary surgical treatment
|
Ex-PRESS + Scleral Flap Suture
n=34 Eyes
Ex-PRESS® Glaucoma Filtration Device with scleral flap suture as a secondary surgical treatment
|
|---|---|---|---|---|---|
|
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
Month 3
|
88 percentage of eyes
|
12 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
|
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
Month 6
|
94 percentage of eyes
|
3 percentage of eyes
|
0 percentage of eyes
|
3 percentage of eyes
|
3 percentage of eyes
|
|
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
Month 12
|
100 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
Adverse Events
Ex-PRESS
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ex-PRESS
n=37 participants at risk
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
|
|---|---|
|
Eye disorders
Choroidal detachment
|
13.5%
5/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Hyphaema
|
10.8%
4/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Macular oedema
|
2.7%
1/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Blebitis
|
2.7%
1/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Corneal epithelium defect
|
5.4%
2/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Macular fibrosis
|
2.7%
1/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Optic disc haemorrhage
|
2.7%
1/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Maculopathy
|
2.7%
1/37 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes."
An AE was defined as all undesirable or unintended signs, symptoms or diseases that occur from the start of the filtration surgery using Ex-PRESS®, regardless of the causal relationship with the filtration surgery using Ex-PRESS®. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
Additional Information
Associate, Medical Group 1, Japan
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER