Trial Outcomes & Findings for Clinical Study Comparing Two Models of a Travoprost Intraocular Implant (NCT NCT03868124)

Last Updated: 2024-11-29

Results Overview

Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

560 participants

Primary outcome timeframe

3 Months

Results posted on

2024-11-29

Participant Flow

subjects required to undergo washout of prior IOP-lowering medication(s) if applicable and to meet inclusion/exclusion criteria

Participant milestones

Participant milestones
Measure	Implant Group 1 G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Overall Study STARTED	185	183	192
Overall Study Month 3	182	182	190
Overall Study Month 12	176	180	183
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	185	183	192

Reasons for withdrawal

Reasons for withdrawal
Measure	Implant Group 1 G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Overall Study Withdrawal by Subject	4	0	1
Overall Study Physician Decision	1	0	1
Overall Study Lost to Follow-up	1	1	2
Overall Study Death	1	1	2
Overall Study Adverse Event	0	0	3
Overall Study Explanted	2	1	0
Overall Study Ongoing in study	176	180	183

Baseline Characteristics

Clinical Study Comparing Two Models of a Travoprost Intraocular Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant Group 1 n=185 Participants G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 n=183 Participants G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group n=192 Participants Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)	Total n=560 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	92 Participants n=5 Participants	100 Participants n=7 Participants	93 Participants n=5 Participants	285 Participants n=4 Participants
Age, Categorical >=65 years	93 Participants n=5 Participants	83 Participants n=7 Participants	99 Participants n=5 Participants	275 Participants n=4 Participants
Age, Continuous	63.1 years STANDARD_DEVIATION 11.8 • n=5 Participants	61.9 years STANDARD_DEVIATION 12.8 • n=7 Participants	63.9 years STANDARD_DEVIATION 12.1 • n=5 Participants	63.0 years STANDARD_DEVIATION 12.2 • n=4 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	88 Participants n=7 Participants	105 Participants n=5 Participants	281 Participants n=4 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	95 Participants n=7 Participants	87 Participants n=5 Participants	279 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 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	26 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants	155 Participants n=7 Participants	162 Participants n=5 Participants	467 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment United States	168 participants n=5 Participants	167 participants n=7 Participants	175 participants n=5 Participants	510 participants n=4 Participants
Region of Enrollment Armenia	17 participants n=5 Participants	16 participants n=7 Participants	17 participants n=5 Participants	50 participants n=4 Participants
Baseline Mean Diurnal IOP	24.4 mmHg STANDARD_DEVIATION 3.21 • n=5 Participants	24.1 mmHg STANDARD_DEVIATION 2.81 • n=7 Participants	24.3 mmHg STANDARD_DEVIATION 2.99 • n=5 Participants	24.3 mmHg STANDARD_DEVIATION 3.00 • n=4 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: intent to treatment analysis set which includes all randomized subjects with analyses performed according to original treatment assignment, regardless of actual treatment received

Outcome measures

Outcome measures
Measure	Implant Group 1 n=185 study eyes G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 n=183 study eyes G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group n=192 study eyes Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Day 10, 8AM	-8.26 mmHg Standard Error 0.27	-8.40 mmHg Standard Error 0.27	-7.16 mmHg Standard Error 0.26
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Day 10, 10AM	-8.20 mmHg Standard Error 0.25	-8.28 mmHg Standard Error 0.25	-7.08 mmHg Standard Error 0.24
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Week 6, 8AM	-6.83 mmHg Standard Error 0.26	-7.20 mmHg Standard Error 0.26	-7.17 mmHg Standard Error 0.26
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Week 6, 10AM	-6.92 mmHg Standard Error 0.25	-6.83 mmHg Standard Error 0.25	-7.15 mmHg Standard Error 0.25
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Month 3, 8AM	-6.29 mmHg Standard Error 0.28	-6.66 mmHg Standard Error 0.27	-6.82 mmHg Standard Error 0.27
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Month 3, 10AM	-6.21 mmHg Standard Error 0.27	-6.79 mmHg Standard Error 0.27	-6.76 mmHg Standard Error 0.26

SECONDARY outcome

Timeframe: 12 Months

Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit

Outcome measures

Outcome data not reported

Adverse Events

Implant Group 1

Serious events: 6 serious events

Other events: 20 other events

Deaths: 1 deaths

Implant Group 2

Serious events: 4 serious events

Other events: 23 other events

Deaths: 1 deaths

Control Group

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Implant Group 1 n=185 participants at risk G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 n=183 participants at risk G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group n=192 participants at risk Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Cardiac disorders Combined adverse events in Cardiac Disorders SOC	2.7% 5/185 • Number of events 5 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	0.55% 1/183 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	0.52% 1/192 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Combined adverse events in Neoplasms SOC	0.54% 1/185 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	1.6% 3/183 • Number of events 3 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	0.52% 1/192 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.

Other adverse events

Other adverse events
Measure	Implant Group 1 n=185 participants at risk G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Implant Group 2 n=183 participants at risk G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. G2-TR intraocular implant containing travoprost: Provided in Arm/Group descriptions	Control Group n=192 participants at risk Sham surgery + active-comparator eye drops Sham surgery + active-comparator eye drops: Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Eye disorders Iritis	4.3% 8/185 • Number of events 8 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	5.5% 10/183 • Number of events 10 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	0.52% 1/192 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.
Investigations intraocular pressure increased	6.5% 12/185 • Number of events 12 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	7.1% 13/183 • Number of events 13 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.	3.1% 6/192 • Number of events 6 • 12 months post-operative The safety analysis set includes all subjects who were randomized and received at least one dose of study treatment. Subjects were grouped according to their actual treatment received, not according to their randomization assignment (as randomized). If subjects were mis-randomized or received incorrect study treatment, they were grouped according to the actual treatment they received.

Additional Information

Study Manager

Glaukos

Phone: 949-481-8076

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 data from this study.
Publication restrictions are in place

Restriction type: OTHER