NCT03284853.

Methods	Randomized parallel trial Masking: participant, care provider, investigator (triple‐masked)
Participants	Inclusion criteria: aged ≥ 18 years; diagnosis of open‐angle glaucoma or ocular hypertension; participants insufficiently controlled or considered in need for combination therapy; medicated IOP ≥ 17 mmHg and < 28 mmHg in both eyes at screening visit; unmedicated (post‐washout) IOP > 20 mmHg in 1 or both eyes and < 36 mmHg in both eyes at 2 qualification visits. At second qualification visit to have IOP > 17 mmHg in 1 or both eyes and < 36 mmHg in both eyes. If only 1 eye qualifies at second qualification visit it MUST be the same eye qualified on the first visit (this will be known as the study eye); best corrected visual acuity +1.0 logMAR or better; willing and able to give informed consent and follow instructions; women must be either of non‐child‐bearing potential, or women with child‐bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during study; women of child‐bearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective birth control from time of randomization and for 3 months after last dose of study medication; men with a female partner of child‐bearing potential must have either had a prior vasectomy or agree to use effective birth control from time of randomization and for 3 months following the last dose of study medication; in France, a person will be eligible for inclusion only if either affiliated to or as a beneficiary of a social security number Exclusion criteria: ophthalmic: clinically significant ocular disease which might interfere with interpretation of the study results, including people with glaucomatous damage so severe that washout of ocular hypotensive medication for ≥ 4 weeks would not be judged as safe; pseudoexfoliation or pigment dispersion glaucoma, history of narrow angles or angle closure glaucoma. Previous laser peripheral iridotomy is not permitted; IOP (note: fixed‐dose combinations, for the purpose of this exclusion criterion count as 1 medication); however, people currently taking 2 fixed‐dose combination products are excluded; treatment‐naïve people; prior treatment with GANFORT topical eye drops, where person's IOP did not achieve target IOP and was considered a failure or an insufficient response; currently (prior to screening visit) being treated with GANFORT; known hypersensitivity to any component of the investigational formulations to be used; previous glaucoma intraocular surgery; refractive surgery in either eye; ocular trauma within 6 months prior to screening, or ocular surgery or non‐refractive laser treatment within 3 months prior to screening; recent or current evidence of ocular infection or inflammation in either eye; use of ocular medication in either eye within 30 days of screening and throughout the study except for permitted ocular medication (which must be the same medication for 30 days prior to screening) as prescribed by the investigator; mean central corneal thickness > 620 μm at screening; any abnormality preventing reliable Goldmann applanation tonometry of either eye. Systemic: clinically significant abnormalities in laboratory tests at screening; known hypersensitivity or contraindication to GANFORT and to beta‐blockers; clinically significant systemic disease that might interfere with the study; participation in any investigational study within 30 days prior to screening; systemic medication (including corticosteroids) that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regimen within 30 days prior to screening, and are anticipated to change in dose or regimen (or both) during the study; use of topical steroids containing medications on the face or in or around the eyes; women of child‐bearing potential who are pregnant, breast‐feeding, planning a pregnancy or not using a medically acceptable and highly effective form of birth control; vulnerable people such as minors, adults under legal protection or unable to express their consent; people deprived of liberty or people subject to psychiatric care
Interventions	Netarsudil 0.02%/latanoprost 0.005% PG‐324 ophthalmic solution; 1 drop per day to each eye for 180 days GANFORT (bimatoprost 0.03%/timolol 0.5%) ophthalmic solution; 1 drop per day to each eye for 180 days
Outcomes	Primary outcome Mean diurnal IOP by Goldmann applanation tonometry at day 90 Secondary outcomes Assessment of anterior segment tissues by slit lamp biomicroscopy at 6 months Assessment of posterior segment tissues by dilated ophthalmoscopy at 6 months Systemic safety of vital signs (heart rate) at 6 months Systemic safety of vital signs (blood pressure/systolic diastolic at 6 months Systemic safety clinical laboratory assessments (hematology and clinical chemistry) at 6 months Assessment of IOP at 6 months
Notes	Phase 3; date completed: 6 November 2020; results submitted to ClinicalTrials.gov on 5 November 2021

COPD: chronic obstructive pulmonary disease; CVS: cardiovascular surgical; IOP: intraocular pressure.