Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.
Interventions
DRUGiDose TR
anchored intracameral implant containing travoprost
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinically significant age-related cataract eligible for phacoemulsification in the study eye * open-angle glaucoma or ocular hypertension in the study eye * successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL
Exclusion criteria
* unmedicated (washed out) IOP of \>36 mmHg in the study eye * hypersensitivity to travoprost or any other components of the travoprost intraocular implant * vertical cup/disc ratio \> 0.8 in the study eye * best spectacle corrected visual acuity of worse than 20/80 in the fellow eye * any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean diurnal IOP | 3 months | Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit |
Countries
Armenia
Outcome results
None listed