Clinical Study Comparing Two Models of a Travoprost Intra... | NCT03868124

Clinical Study Comparing Two Models of a Travoprost Intra... | NCT03868124 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implant Group 1	Experimental	G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.	Combination Product: G2-TR intraocular implant containing travoprost
Implant Group 2	Experimental	G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.	Combination Product: G2-TR intraocular implant containing travoprost
Control Group	Active Comparator	Sham surgery + active-comparator eye drops	Drug: Sham surgery + active-comparator eye drops

Name	Type	Description	Arm Group Labels	Other Names
G2-TR intraocular implant containing travoprost	Combination Product	Provided in Arm/Group descriptions	Implant Group 1 Implant Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative	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.	3 Months

Secondary Outcomes

Measure	Description	Time Frame
Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative	Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit	12 Months

Contacts/Locations Module

Name	Affiliation	Role
Kerry Stephens, OD	Glaukos Corporation	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Center for Sight		Las Vegas	Nevada	89145	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41046316	Derived	Singh IP, Reiss GR, Flowers BE, Katz LJ, Usner DW, Applegate D, Kothe AC, Navratil T. Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting. Ophthalmol Ther. 2025 Dec;14(12):3109-3118. doi: 10.1007/s40123-025-01254-4. Epub 2025 Oct 4.
39240530	Derived	Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6.

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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
FG002	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%)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000185 subjects FG001183 subjects FG002192 subjects
Month 3		FG000182 subjects FG001182 subjects FG002190 subjects
Month 12		FG000176 subjects FG001180 subjects FG002183 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG000185 subjects FG001183 subjects FG002192 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0004 subjects FG0010 subjects FG0021 subjects
Physician Decision		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Implant Group 2

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative

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.

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

Posted

Least Squares Mean

Standard Error

mmHg

3 Months

study eyes

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Combined adverse events in Cardiac Disorders SOC	Cardiac disorders	MedDRA 21.0	Non-systematic Assessment	All AEs in SOC combined to prevent unmasking in this ongoing double-masked trial

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Iritis	Eye disorders	MedDRA 21.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Study Manager	Glaukos	949-481-8076		ldoan@glaukos.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 26, 2022	Jul 20, 2023	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jul 27, 2022	Jul 20, 2023	SAP_001.pdf

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Intervention Browse Module

ID	Term
D035061	Control Groups

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Day 10, 8AM

Title	Measurements
	OG000-8.26± 0.27 OG001-8.40± 0.27 OG002-7.16± 0.26

Day 10, 10AM

Title	Measurements
	OG000-8.20± 0.25 OG001-8.28± 0.25 OG002-7.08± 0.24

Week 6, 8AM

Title	Measurements
	OG000-6.83± 0.26 OG001-7.20± 0.26 OG002-7.17± 0.26

Week 6, 10AM

Title	Measurements
	OG000-6.92± 0.25 OG001-6.83± 0.25 OG002-7.15± 0.25

Month 3, 8AM

Title	Measurements
	OG000-6.29± 0.28 OG001-6.66± 0.27 OG002-6.82± 0.27

Month 3, 10AM

Title	Measurements
	OG000-6.21± 0.27 OG001-6.79± 0.27 OG002-6.76± 0.26

Group IDs	Group Description	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG001 OG002	Day 10, 8AM Difference between Implant Group 2 and timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-1.25	2-Sided	95	-1.99	-0.50	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG001 OG002	Month 3, 10AM Difference between Implant Group 2 and timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-1.20	2-Sided	95	-1.88	-0.52	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG001 OG002	Week 6, 8AM Difference between Implant Group 2 and timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-0.03	2-Sided	95	-0.76	0.69	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG001 OG002	Week 6, 10AM Difference between Implant Group 2 and Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.32	2-Sided	95	-0.37	1.01	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG001 OG002	Month 3, 8AM Difference between Implant Group 2 and timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.16	2-Sided	95	-0.59	0.91	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG001 OG002	Month 3, 10AM Difference between Implant Group 2 and timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-0.03	2-Sided	95	-0.77	0.71	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol
OG000 OG002	Day 10, 8AM Difference between Implant Group 1 vs. Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-1.10	2-Sided	95	-1.84	-0.36	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol
OG000 OG002	Day 10, 10AM Difference between Implant Group 1 vs. Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	-1.13	2-Sided	95	-1.81	-0.45	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol
OG000 OG002	Week 6, 8AM Difference between Implant Group 1 vs. Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.33	2-Sided	95	-0.39	1.06	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol
OG000 OG002	Week 6, 10AM Difference between Implant Group 1 vs. Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.23	2-Sided	95	-0.46	0.93	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol
OG000 OG002	Month 3, 8AM Difference between Implant Group 1 and Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.53	2-Sided	95	-0.23	1.28	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol
OG000 OG002	Month 3, 10AM Difference between Implant Group 1 and Timolol Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses	Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol	Mean Difference (Final Values)	0.55	2-Sided	95	-0.19	1.29	Non-Inferiority	criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was < 1.5 mmHg and also < 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol