EUCTR2009‐018066‐36‐ES.

Trial name or title	Evaluación aleatorizada prospectiva en abierto del iStent® (GTS400) frente a dos agentes hipotensores oculares en pacientes con glaucoma primario de ángulo abierto – second line study [Open prospective randomized evaluation of iStent® (GTS400) versus two ocular hypotensive agents in patients with primary open‐angle glaucoma]
Methods	Study design: parallel‐group RCT Unit of randomization: not reported Number randomized: not reported Unit of analysis: not reported Number analyzed: not reported Exclusions and losses to follow‐up: not reported Handling of missing data: not reported
Participants	Country: Spain Age: not reported Gender: not reported Inclusion criteria: Diagnosis by researchers of primary open angle glaucoma (including pseudoexfoliation or pigmentary glaucoma) Male or female, at least 18 years of age and able to give written informed consent Diurnal untreated mean IOP (at the initial visit after having rested from all medication taken) of at least 22 mmHg, but less than 38 mmHg The scleral spur of the patient must be clearly visible with the gonioscope Able to attend follow‐up visits No prior incisional surgery or laser interventions to treat glaucoma; previous surgery for cataracts is acceptable Minimum BCVA of 20/200 or better Exclusion criteria: not reported (in Spanish) Diagnoses in participants: OAG
Interventions	Intervention 1: iStent Intervention 2: latanoprost; timolol Length of follow‐up: not reported
Outcomes	Primary outcomes: Mean IOP at each visit for the study; mean reduction in IOP; percentage of patients achieving an objective IOP> 18 mmHG; responses to the patient's questionnaire Secondary outcomes: not reported Safety outcomes: not reported
Starting date	11 March 2010
Contact information	No contact details
Notes	Type of study: awaiting classification Funding source: Glaukos Corporation, Laguna Hills, CA, USA provided funding/support Disclosures of interest: not reported Publication language: not reported Trial registration: EudraCT Number 2009‐018066‐36