AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

  • STATUS
    Recruiting
  • End date
    Apr 26, 2025
  • participants needed
    84
  • sponsor
    Allergan
Updated on 21 September 2021
hypertension
glaucoma
brimonidine tartrate ophthalmic solution
bimatoprost
intraocular pressure
pigmentary glaucoma
pseudoexfoliation glaucoma
lumigan

Summary

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

Details
Condition EYE DISORDER, Ocular Hypertension, Glaucoma, Pigmentary glaucoma, Eye Disorders/Infections, Dry Eye Disease, Eye Disorders/Infections (Pediatric), Eye Disease, Open Angle Glaucoma
Treatment LUMIGAN, AGN-193408 SR, Sham Administration, Lumigan Vehicle
Clinical Study IdentifierNCT04499248
SponsorAllergan
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

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 a 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
History of anatomically narrow angle resulting in evidence of angle changes or any history or closed angle glaucoma in the study eye
History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye
Any history of trabeculectomy or other types of glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye
Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within: a. 3 years: intraocular fluocinolone acetonide b. 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid c. 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids d. 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa
3 years: intraocular fluocinolone acetonide
6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid
2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids
2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa
Anticipated use of other topical ocular medications in either eye except for permitted interventions
Use of contact lenses of any kind should be discontinued for 1 week following any AGN-193408 SR administration
The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohort 2) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following)
Central corneal thickness of < 480 or > 620 micrometers in both eyes
Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline
Anticipated need for any incisional or laser ocular surgery in either eye during the study
Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit
History of anatomically narrow angle resulting in evidence of angle changes or any history of closed angle glaucoma in the study eye
History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye
Any history of trabeculectomy or other types of incisional glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye
Peripheral anterior synechiae (PAS) in the inferior iridocorneal angle on gonioscopic examination at Screening in the study eye
Visual field loss in the study eye that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to Baseline
Evidence of macular edema in either eye during screening or in participant's medical history
Anticipated use of corticosteroids in either eye (except as described in Section 6.4.1) or systemically during the study, or historical use prior to Baseline within
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