Trial Outcomes & Findings for Study of Exchange of Travoprost Intraocular Implant (NCT NCT04615403)

NCT ID: NCT04615403

Last Updated: 2023-09-26

Results Overview

Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2023-09-26

Participant Flow

Participant milestones

Measure	Implantation and Exchange Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Implantation and Exchange Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Overall Study Death	1

Baseline Characteristics

Study of Exchange of Travoprost Intraocular Implant

Baseline characteristics by cohort

Measure	Implantation and Exchange n=33 Participants Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	65.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Duration since initial implant administration	1540.8 days STANDARD_DEVIATION 123.7 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Safety population (all subjects who underwent the exchange procedure)

Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye

Outcome measures

Measure	Implantation and Exchange n=33 Participants Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Ocular Safety	13 subjects

Adverse Events

Implantation and Exchange

Serious events: 2 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Measure	Implantation and Exchange n=33 participants at risk Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
General disorders Death	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Retinal vein occlusion	3.0% 1/33 • Number of events 1 • 12 months

Other adverse events

Measure	Implantation and Exchange n=33 participants at risk Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Travoprost: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Eye disorders Eye irritation	6.1% 2/33 • Number of events 2 • 12 months
Eye disorders Corneal pigmentation	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Diabetic retinopathy	3.0% 1/33 • Number of events 2 • 12 months
Eye disorders Iridodialysis	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Photophobia	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Posterior capsule opacification	3.0% 1/33 • Number of events 2 • 12 months
Eye disorders Retinal hemorrhage	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Hordeolum	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Conjunctivitis viral	3.0% 1/33 • Number of events 1 • 12 months
Eye disorders Corneal abrasion	3.0% 1/33 • Number of events 1 • 12 months
Infections and infestations Corona virus infection	6.1% 2/33 • Number of events 2 • 12 months
Infections and infestations Ear infection	3.0% 1/33 • Number of events 1 • 12 months
Metabolism and nutrition disorders Gout	3.0% 1/33 • Number of events 1 • 12 months
Nervous system disorders Atonic seizures	3.0% 1/33 • Number of events 1 • 12 months
Nervous system disorders Cerebral arteriosclerosis	3.0% 1/33 • Number of events 1 • 12 months
Nervous system disorders Trigeminal neuralgia	3.0% 1/33 • Number of events 1 • 12 months
Nervous system disorders Visual field defect	9.1% 3/33 • Number of events 3 • 12 months
Investigations Intraocular pressure increased	6.1% 2/33 • Number of events 2 • 12 months

Additional Information

Study Manager

Glaukos

Phone: 949-481-8076

Email: ldoan@glaukos.com

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