Phase 3 Efficacy Study of AGN-190584 in Participants With Presbyopia
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - 55 |
| Updated: | 3/6/2019 |
| Start Date: | December 21, 2018 |
| End Date: | March 31, 2020 |
| Contact: | Clinical Trials Registry Team |
| Email: | IR-CTRegistration@allergan.com |
| Phone: | 877-277-8566 |
Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
A study to evaluate the efficacy, safety, and pharmacokinetics of AGN-190584 when
administered bilaterally, once daily for 30 days in participants with presbyopia.
administered bilaterally, once daily for 30 days in participants with presbyopia.
Inclusion Criteria:
- Subjective complaints of poor near vision that impact activities of daily living
Exclusion Criteria:
- History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery,
radial keratotomy, or any intraocular surgery
- Use of any topical ophthalmic medications, including artificial tears other than the
study medications during the study
- Use of temporary or permanent punctal plugs or history of punctal cautery in one or
both eyes
- Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial
dystrophy, guttata, or edema) in either eye that are likely to interfere with visual
acuity
- Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination),
history of angle-closure glaucoma, or previous iridotomy
- Diagnosis of any type of glaucoma or ocular hypertension
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