JPRN-jRCT2031220053
Recruiting
Phase 1
A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
Yamazaki Hayato0 sites84 target enrollmentMay 10, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Open-angle glaucoma
- Sponsor
- Yamazaki Hayato
- Enrollment
- 84
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk.
- •\- Diagnosis of either OAG \[open\-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.
Exclusion Criteria
- •\- Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure\-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone\-iodine).
- •\- Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit.
- •\- History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX\-TIC, ENV515 Travoprost XR).
- •\- History of laser trabeculoplasty within 6 months prior to screening in the study eye.
- •\- History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye.
- •\- History or evidence of complicated cataract/lens surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[IOL], sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss], substantial iris trauma, etc.).
- •\- Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration.
- •\- Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty \[DSEK], Descemet's Membrane Endothelial Keratoplasty \[DMEK] );or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye.
- •\- History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus).
- •\- Anticipated need for any incisional or laser ocular surgery in either eye during the study.
Outcomes
Primary Outcomes
Not specified
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