A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

NCT03857542 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 1883-302-013
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 35

Brief Summary

This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA, Without Losing More Than 5 Letters of Mesopic, High-Contrast, Binocular CDVA With the Same Refractive Correction at Day 30, Hour 3

  Visual acuity for near (40 centimeter (cm)) and distance (4 meter (m)) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions measured at the target. Forced choice letter by-letter scoring was used for each test and the total number of correct letters or the highest value (number) of the grid identified (as applicable) were recorded. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. DCNVA= distance-corrected near visual acuity.

  Baseline (Day 1) to Day 30 (Hour 3)

Secondary Outcomes (12)

• Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular DCNVA at Day 30, Hour 6

  Baseline (Day 1) to Day 30 (Hour 6)

• Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8

  Baseline (Day 1) to Day 30 (Hour 8)

• Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5

  Baseline (Day 1) to Day 30 (Hour 0.5)

• Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular DCNVA at Day 30, Hour 1

  Day 30 (Hour 1)

• Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3

  Baseline (Day 1) to Day 30 (Hour 3)

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Participants received one drop of vehicle in each eye, once daily, for up to 30 days.

Other: Vehicle

Pilocarpine HCl Ophthalmic Solution

EXPERIMENTAL

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days.

Drug: Pilocarpine HCl Ophthalmic Solution

Interventions

Pilocarpine HCl Ophthalmic Solution DRUG

Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.

Also known as: AGN-190584, VUITY

Pilocarpine HCl Ophthalmic Solution

Vehicle OTHER

Vehicle, one drop in each eye, once daily, for up to 30 days.

Vehicle

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjective complaints of poor near vision that impact activities of daily living

You may not qualify if:

• Uncontrolled systemic disease
• Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications
• Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study
• Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
• Participation in a blood or plasma donation program within 30 days prior to study intervention administration
• Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit
• 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
• History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit
• Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy
• Diagnosis of any type of glaucoma or ocular hypertension
• Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled
• Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history
• Females who are pregnant, nursing, or planning a pregnancy during the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (35)

Eye Center South

Dothan, Alabama, 36301, United States

Location

M&M Eye Institute

Prescott, Arizona, 86301, United States

Location

Walman Eye Center

Sun City, Arizona, 85351, United States

Location

Milton M. Hom, OD, FAAO

Azusa, California, 91702, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

North Valley Eye Medical Group, Inc.

Mission Hills, California, 91345, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Corneal Consultants of Colorado

Littleton, Colorado, 80120, United States

Location

Benjamin Knox Lambright, MD

Crystal River, Florida, 34429, United States

Location

South Florida Vision Center

Fort Lauderdale, Florida, 33309, United States

Location

Bowden Eye Associates

Jacksonville, Florida, 32256, United States

Location

Mid Florida Eye Center

Mt. Dora, Florida, 32757, United States

Location

Newsom Eye & Laser Center

Sebring, Florida, 33870, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

The Midwest Center for Sight

Des Plaines, Illinois, 60016, United States

Location

Jacksoneye

Lake Villa, Illinois, 60046, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eyecare

Shawnee Mission, Kansas, 66204, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Chu Laser Eye Institute

Bloomington, Minnesota, 55420, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Amel Youssef, OD

Las Vegas, Nevada, 89117, United States

Location

Debry Medical Services PC

Las Vegas, Nevada, 89128, United States

Location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Waring Vision Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

University Eye Surgeons

Maryville, Tennessee, 37803, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Keystone Research ltd. at Texan Eye

Austin, Texas, 78731, United States

Location

The Cataract and Glaucoma Center

El Paso, Texas, 79902, United States

Location

Texas Eye & Laser Ctr

Hurst, Texas, 76054, United States

Location

Benjamin Travis Dastrup, MD

Ogden, Utah, 84403, United States

Location

Vision Consultants and Surgeons

Falls Church, Virginia, 22046, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

DCNVA measurements at 1 site were not conducted correctly at the screening and baseline visits; all participants from this site were excluded from efficacy analyses.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Eleonora Safyan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: March 1, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: December 29, 2021
• Results First Posted: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.

Locations

US (35)