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. 2022 Jun 10;2022(6):CD013817. doi: 10.1002/14651858.CD013817.pub2

CTRI/2018/04/013091.

Methods Randomized, parallel group, active controlled trial
Method of generating randomization sequence: computer‐generated randomization 
Method of allocation concealment: sequentially numbered, sealed, opaque envelopes 
Masking: participant and investigator (double‐masked)
Participants Inclusion criteria: people with IOP 22–30 mmHg at time of screening in any 1 eye. In case both eyes are affected then the eye fulfilling the criteria will be considered for the evaluations. If both eyes fulfill the criteria, then the right eye will be considered for the study; voluntary willingness of person to give written informed consent prior to participation in trial
Exclusion criteria: women who are not using an effective means of birth control or who are pregnant or breast‐feeding; any severe or advanced cases of glaucoma; Shaffer angle grade < 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, > 20]), as measured by gonioscopy; people who are blind or have a single eye; severe central visual field loss in either eye measured by perimetry; cup–disk ratio > 0.80; scheduled to undergo eye surgery during the study; history of/current chronic, recurrent or severe inflammatory eye disease (e.g. scleritis, uveitis, herpes keratitis) or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study; history of ocular trauma or any other intraocular surgery within the past 6 months in either eye; current/history of ocular infection or inflammation within the past 3 months as determined by patient history or eye examination, or both
Interventions
  • Ripasudil hydrochloride hydrate eye drops 0.4% w/v: 1 drop in the affected eye twice per day for 90 days

  • Timolol maleate eye drops 0.5% w/v: 1 drop into the affected eye twice per day for 90 days

Outcomes Primary outcome
  • Mean reduction in IOP from baseline to end of study visit. Time point: day 0 and day 90


Secondary outcome
  • Mean reduction in the phasing of IOP from baseline to end of study visit. Time point: day 0 and day 90

Notes Phase 3; date completed: 12 June 2018