A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Browse trials for

• Glaucoma 1,818
• Glaucoma, Open-Angle 929
• Ocular Hypertension 649
• Hypertension 6,689

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 253 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Lead sponsor

Santen Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 1 is open to participants now.

Study arms

• Placebo comparator
  Placebo ophthalmic solution

  Eyedrop

  Drug: Placebo ophthalmic solution

• Experimental
  DE-117 ophthalmic solution low

  Eyedrop

  Drug: DE-117 ophthalmic solution low

• Experimental
  DE-117 ophthalmic solution high

  Eyedrop

  Drug: DE-117 ophthalmic solution high

• Active comparator
  Latanoprost ophthalmic solution 0.005%

  Eyedrop

  Drug: Latanoprost ophthalmic solution 0.005%

Interventions

• DrugPlacebo ophthalmic solution
• DrugDE-117 ophthalmic solution low
• DrugDE-117 ophthalmic solution high
• DrugLatanoprost ophthalmic solution 0.005%

  Also known as: Latanoprost

Primary outcomes

1. Intraocular pressure

   Time frame: Week 4

Publications

• Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10. Erratum In: Am J Ophthalmol. 2021 Nov;231:211. doi: 10.1016/j.ajo.2021.03.002. PubMed 32533949 ↗