Trial Outcomes & Findings for Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5% (NCT NCT03519386)

NCT ID: NCT03519386

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

590 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	200	197	193
Overall Study Month 3	196	195	189
Overall Study Month 12	190	192	183
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	200	197	193

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	1	2
Overall Study Physician Decision	1	1	1
Overall Study Lost to Follow-up	0	1	1
Overall Study Death	1	0	4
Overall Study Adverse Event	2	1	2
Overall Study Explanted	2	1	0
Overall Study Ongoing in study	190	192	183

Baseline Characteristics

Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant Group 1 n=200 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=197 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=193 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=590 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	102 Participants n=5 Participants	91 Participants n=7 Participants	93 Participants n=5 Participants	286 Participants n=4 Participants
Age, Categorical >=65 years	98 Participants n=5 Participants	106 Participants n=7 Participants	100 Participants n=5 Participants	304 Participants n=4 Participants
Age, Continuous	63.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	63.2 years STANDARD_DEVIATION 12.6 • n=7 Participants	63.8 years STANDARD_DEVIATION 11.4 • n=5 Participants	63.6 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	99 Participants n=7 Participants	108 Participants n=5 Participants	316 Participants n=4 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	98 Participants n=7 Participants	85 Participants n=5 Participants	274 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	191 Participants n=5 Participants	179 Participants n=7 Participants	180 Participants n=5 Participants	550 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	38 Participants n=5 Participants	50 Participants n=7 Participants	41 Participants n=5 Participants	129 Participants n=4 Participants
Race (NIH/OMB) White	143 Participants n=5 Participants	120 Participants n=7 Participants	128 Participants n=5 Participants	391 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	186 participants n=5 Participants	183 participants n=7 Participants	179 participants n=5 Participants	548 participants n=4 Participants
Region of Enrollment Philippines	14 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	42 participants n=4 Participants
Baseline Mean Diurnal IOP	24.2 mmHg STANDARD_DEVIATION 2.78 • n=5 Participants	24.0 mmHg STANDARD_DEVIATION 2.81 • n=7 Participants	24.1 mmHg STANDARD_DEVIATION 2.68 • n=5 Participants	24.1 mmHg STANDARD_DEVIATION 2.76 • 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=200 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=197 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=193 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	-8.40 mmHg Standard Error 0.24	-8.48 mmHg Standard Error 0.24	-7.69 mmHg Standard Error 0.24
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Day 10, 10AM	-8.35 mmHg Standard Error 0.24	-8.44 mmHg Standard Error 0.24	-7.20 mmHg Standard Error 0.24
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Week 6, 8AM	-7.34 mmHg Standard Error 0.24	-7.26 mmHg Standard Error 0.25	-7.09 mmHg Standard Error 0.25
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Week 6, 10AM	-7.59 mmHg Standard Error 0.24	-7.62 mmHg Standard Error 0.24	-6.85 mmHg Standard Error 0.24
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Month 3, 8AM	-6.59 mmHg Standard Error 0.26	-6.59 mmHg Standard Error 0.26	-6.69 mmHg Standard Error 0.27
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative Month 3, 10AM	-6.56 mmHg Standard Error 0.26	-6.68 mmHg Standard Error 0.26	-6.52 mmHg Standard Error 0.27

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: 5 serious events

Other events: 16 other events

Deaths: 2 deaths

Implant Group 2

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Control Group

Serious events: 7 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Implant Group 1 n=200 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=195 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=194 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	0.50% 1/200 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	1.5% 3/195 • Number of events 3 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	1.0% 2/194 • Number of events 2 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.
Musculoskeletal and connective tissue disorders Combined adverse events in Musculoskeletal and Connective Tissue Disorders SOC	1.0% 2/200 • Number of events 2 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	0.51% 1/195 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	1.0% 2/194 • Number of events 2 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.
Infections and infestations Combined adverse events in Infections and Infestations SOC	0.50% 1/200 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	0.51% 1/195 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	1.0% 2/194 • Number of events 2 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.
Psychiatric disorders Combined adverse events in Psychiatric Disorders SOC	0.50% 1/200 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	0.51% 1/195 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	0.52% 1/194 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.

Other adverse events

Other adverse events
Measure	Implant Group 1 n=200 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=195 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=194 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	0.50% 1/200 • Number of events 1 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	6.2% 12/195 • Number of events 12 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	0.00% 0/194 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.
Investigations intraocular pressure increased	7.5% 15/200 • Number of events 15 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	4.6% 9/195 • Number of events 9 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.	2.1% 4/194 • Number of events 4 • 12 months post-operative The safety analysis set includes all subjects who were randomized \& received \>= 1 dose of study treatment, with subjects grouped according to their actual treatment received. 1 subject was randomized \& not treated, \& 4 subjects received treatment that differed from their randomization assignment: 1 randomized to Group 1 was treated with Control; 1 randomized to Control was treated as Group 1; 1 randomized to Group 2 was treated with Control; and 1 randomized to Group 2 was treated as Group 1.

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