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
- Registration Number
- NCT04983589
- Lead Sponsor
- Allergan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
- Objective and subjective evidence of presbyopia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days. AGN-190584 Pilocarpine HCl AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.
- Primary Outcome Measures
Name Time Method 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 3 hours after second dose on Day 14 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.
- Secondary Outcome Measures
Name Time Method 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 3 hours after second dose on Day 14 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.
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 3 hours after second dose on Day 14 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.
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 3 hours after second dose on Day 14 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.
Trial Locations
- Locations (23)
Martel Eye Medical Group /ID# 231332
🇺🇸Rancho Cordova, California, United States
North Valley Eye Medical Group, Inc. /ID# 231270
🇺🇸Mission Hills, California, United States
Global Research Management /ID# 231300
🇺🇸Glendale, California, United States
Bruce Segal, MD /ID# 231413
🇺🇸Delray Beach, Florida, United States
Price Vision Group /ID# 231261
🇺🇸Indianapolis, Indiana, United States
Jacksoneye, SC /ID# 231374
🇺🇸Lake Villa, Illinois, United States
Kannarr Eye Care /ID# 231363
🇺🇸Pittsburg, Kansas, United States
Eye associates /ID# 231262
🇺🇸San Antonio, Texas, United States
Total Eye Care, PA /ID# 231245
🇺🇸Memphis, Tennessee, United States
Empire Eye and Laser /ID# 231433
🇺🇸Bakersfield, California, United States
United Medical Research Institute /ID# 233982
🇺🇸Inglewood, California, United States
The Eye Research Foundation /ID# 231274
🇺🇸Newport Beach, California, United States
Nature Coast Clinical Research - Crystal River /ID# 231298
🇺🇸Crystal River, Florida, United States
Clayton Eye Clinical Research, LLC /ID# 231243
🇺🇸Morrow, Georgia, United States
The Eye Care Institute /ID# 231275
🇺🇸Louisville, Kentucky, United States
Cincinnati Eye Institute- Edgewood /ID# 231356
🇺🇸Edgewood, Kentucky, United States
Advancing Vision Research /ID# 231244
🇺🇸Smyrna, Tennessee, United States
Hill Country Eye Center /ID# 231293
🇺🇸Cedar Park, Texas, United States
Southern College of Optometry /ID# 231325
🇺🇸Memphis, Tennessee, United States
The Cataract & Glaucoma Center /ID# 231292
🇺🇸El Paso, Texas, United States
Hoopes, Durrie, Rivera Research /ID# 231273
🇺🇸Draper, Utah, United States
Country Hills Eye Center /ID# 231414
🇺🇸Ogden, Utah, United States
Rochester Ophthalmological Group PC /ID# 231371
🇺🇸Rochester, New York, United States