Trial Outcomes & Findings for Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract (NCT NCT00721968)

NCT ID: NCT00721968

Last Updated: 2014-03-06

Results Overview

Percent reaching this endpoint

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2014-03-06

Participant Flow

62 enrolled and 44 randomized. Therefore 18 subjects enrolled who either did not pass baseline visit or were not randomized to the trial.

Participant milestones

Measure	1 Treatment Group: iStent + Cataract Surgery Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only Control Group (Group 2): Cataract surgery only
Overall Study STARTED	27	17
Overall Study COMPLETED	25	17
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	1 Treatment Group: iStent + Cataract Surgery Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only Control Group (Group 2): Cataract surgery only
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Baseline characteristics by cohort

Measure	1 Treatment Group: iStent + Cataract Surgery n=27 Participants Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only n=17 Participants Control Group (Group 2): Cataract surgery only	Total n=44 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
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	17 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications

Percent reaching this endpoint

Outcome measures

Measure	1 Treatment Group: iStent + Cataract Surgery n=27 Participants Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only n=17 Participants Control Group (Group 2): Cataract surgery only
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications	18 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	1 Treatment Group: iStent + Cataract Surgery n=25 Participants Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only n=17 Participants Control Group (Group 2): Cataract surgery only
Number of Ocular Hypotensive Medications by Visit	0.4 medications Standard Deviation 0.8	0.9 medications Standard Deviation 0.7

Adverse Events

1 Treatment Group: iStent + Cataract Surgery

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

2 Control Group: Cataract Surgery Only

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1 Treatment Group: iStent + Cataract Surgery n=27 participants at risk Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery	2 Control Group: Cataract Surgery Only n=17 participants at risk Control Group (Group 2): Cataract surgery only
Eye disorders IOP increase >=10 mmHg versus baseline IOP at any visit	11.1% 3/27 • Number of events 3	52.9% 9/17 • Number of events 9
Eye disorders Posterior Capsule Opacification	14.8% 4/27 • Number of events 4	5.9% 1/17 • Number of events 1
Eye disorders Corneal Abrasion	7.4% 2/27 • Number of events 2	5.9% 1/17 • Number of events 1
Eye disorders Conjunctivitis	11.1% 3/27 • Number of events 3	11.8% 2/17 • Number of events 2
Eye disorders Iritis	7.4% 2/27 • Number of events 2	0.00% 0/17
Eye disorders Punctate Corneal Staining	3.7% 1/27 • Number of events 1	5.9% 1/17 • Number of events 1
Eye disorders Superficial Punctate Keratitis	3.7% 1/27 • Number of events 1	5.9% 1/17 • Number of events 1
Eye disorders BCVA Loss greater than or equal to 1 line after 3 months post-op	0.00% 0/27	11.8% 2/17 • Number of events 2
Eye disorders Eye pain	0.00% 0/27	11.8% 2/17 • Number of events 2
Eye disorders Blurry Vision	3.7% 1/27 • Number of events 1	5.9% 1/17 • Number of events 1
Eye disorders Retinal Detachment	0.00% 0/27	5.9% 1/17 • Number of events 1

Additional Information

Jeff Wells. Sr VP, Clinical, Regulatory, and Quality Affairs

Glaukos

Phone: 949-367-9600

Email: jwells@glaukos.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place