Glaucoma
Conditions
Keywords
Open Angle Glaucoma, Ocular hypertension
Brief summary
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Detailed description
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension
Interventions
Travoprost
Timolol 0.5%
PROCEDURESham Procedure
Sham implant administration
OTHERplacebo eye drops
Artificial Tears
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The study is double-masked in which treatments will be unknown to the subject and to the site staff performing certain outcome measurements
Intervention model description
Subjects will be randomized to undergo initial implant of an intracameral implant and prescription of artificial tears or a sham procedure and prescription of timolol. Subjects will be assessed for eligibility for an exchange procedure at 12, 24 or 36 months and followed for an additional 12 months
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye
Exclusion criteria
* Prior incisional glaucoma surgery in the study eye * Prior argon laser trabeculoplasty (ALT) in the study eye * Prior minimally invasive glaucoma (MIGS) surgery in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 3 months | Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits |
Countries
United States
Contacts
CONTACTStudy Director
Outcome results
None listed