A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily

Presbyopia Clinical Trial

— Virgo  

Official title:

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983589
• Other study ID #: M21-195
• Status: Completed
• Phase: Phase 3
• Start date: September 2, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: March 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States. Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days. There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• Objective and subjective evidence of presbyopia.

Exclusion Criteria:

• 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.
• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• Pilocarpine HCl
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
• Vehicle
Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.

Locations

Country	Name	City	State
United States	Empire Eye and Laser /ID# 231433	Bakersfield	California
United States	Hill Country Eye Center /ID# 231293	Cedar Park	Texas
United States	Nature Coast Clinical Research - Crystal River /ID# 231298	Crystal River	Florida
United States	Bruce Segal, MD /ID# 231413	Delray Beach	Florida
United States	Hoopes, Durrie, Rivera Research /ID# 231273	Draper	Utah
United States	Cincinnati Eye Institute- Edgewood /ID# 231356	Edgewood	Kentucky
United States	The Cataract & Glaucoma Center /ID# 231292	El Paso	Texas
United States	Global Research Management /ID# 231300	Glendale	California
United States	Price Vision Group /ID# 231261	Indianapolis	Indiana
United States	United Medical Research Institute /ID# 233982	Inglewood	California
United States	Jacksoneye, SC /ID# 231374	Lake Villa	Illinois
United States	The Eye Care Institute /ID# 231275	Louisville	Kentucky
United States	Southern College of Optometry /ID# 231325	Memphis	Tennessee
United States	Total Eye Care, PA /ID# 231245	Memphis	Tennessee
United States	North Valley Eye Medical Group, Inc. /ID# 231270	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC /ID# 231243	Morrow	Georgia
United States	The Eye Research Foundation /ID# 231274	Newport Beach	California
United States	Country Hills Eye Center /ID# 231414	Ogden	Utah
United States	Kannarr Eye Care /ID# 231363	Pittsburg	Kansas
United States	Martel Eye Medical Group /ID# 231332	Rancho Cordova	California
United States	Rochester Ophthalmological Group PC /ID# 231371	Rochester	New York
United States	Eye associates /ID# 231262	San Antonio	Texas
United States	Advancing Vision Research /ID# 231244	Smyrna	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction	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 (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14
Secondary	Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction	Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in photopic 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 photopic lighting conditions (= 251 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in photopic, high contrast, binocular DCNVA with no more than 5-letter loss in photopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14
Secondary	Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction	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 photopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 2 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14
Secondary	Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction	Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who achieved 20/40 or better in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder.	3 hours after second dose on Day 14

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