Status:
COMPLETED
A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
Lead Sponsor:
AbbVie
Conditions:
Presbyopia
Eligibility:
All Genders
40-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in...
Eligibility Criteria
Inclusion
- In good general health at the screening visit, as determined by the investigator from medical history.
- Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score \> = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals.
- Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder \< = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit.
- Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles.
- Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening
- Photopic, high-contrast near visual acuity correctable to 20/40 or better in each eye at the screening visit.
- Mesopic pupil diameter \< 8.0 mm in both eyes at the screening visit.
Exclusion
- 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 in either eye that are likely to interfere with visual acuity.
- Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy.
- Diagnosis of any type of glaucoma or ocular hypertension.
- Females who are pregnant, nursing, or planning a pregnancy during the study.
- Uncontrolled systemic disease.
- Severe dry eye disease.
- History of iris trauma.
- Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04837482
Start Date
May 14 2021
End Date
December 7 2021
Last Update
October 10 2024
Active Locations (1)
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1
School of Optometry and Vision Science, Queensland University of Technology /ID# 226378
Brisbane, Queensland, Australia, 4059