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

NCT ID: NCT04837482

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2021-12-07

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 disease symptoms will be assessed.

AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.

This crossover study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled at 1 site in Australia.

Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days, Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days, Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AGN-190584 Sequence 1

AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).

Group Type: EXPERIMENTAL

AGN-190584

Intervention Type: DRUG

Topical eyedrop

Vehicle

Intervention Type: DRUG

Topical eyedrop

AGN-190584 Sequence 2

AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).

Group Type: EXPERIMENTAL

AGN-190584

Intervention Type: DRUG

Topical eyedrop

Vehicle

Intervention Type: DRUG

Topical eyedrop

Interventions

AGN-190584

Topical eyedrop

Intervention Type: DRUG

Vehicle

Topical eyedrop

Intervention Type: DRUG

Other Intervention Names

Pilocarpine hydrochloride, 1.25%; Pilocarpine HCl Placebo

Eligibility Criteria

Inclusion Criteria

• 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 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 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

School of Optometry and Vision Science, Queensland University of Technology /ID# 226378

Brisbane, Queensland, Australia

Countries

Australia

References

Waring GO 4th, Brujic M, McGee S, Micheletti JM, Zhao C, Schachter S, Liu H, Safyan E. Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Clin Exp Optom. 2024 Aug;107(6):665-672. doi: 10.1080/08164622.2023.2279189. Epub 2023 Dec 3.

Reference Type: DERIVED

PMID: 38044272 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1883-306-013

Identifier Type: -

Identifier Source: org_study_id