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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
230
Pilocarpine HCl ophthalmic solution 1.25% ocular drops.
Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Empire Eye and Laser /ID# 231433
Bakersfield, California, United States
Global Research Management /ID# 231300
Glendale, California, United States
United Medical Research Institute /ID# 233982
Inglewood, California, United States
North Valley Eye Medical Group, Inc. /ID# 231270
Mission Hills, California, United States
The Eye Research Foundation /ID# 231274
Newport Beach, California, United States
Martel Eye Medical Group /ID# 231332
Rancho Cordova, California, 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
Clayton Eye Clinical Research, LLC /ID# 231243
Morrow, Georgia, United States
Jacksoneye, SC /ID# 231374
Lake Villa, Illinois, United States
...and 13 more locations
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.
Time frame: 3 hours after second dose on Day 14
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.
Time frame: 3 hours after second dose on Day 14
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.
Time frame: 3 hours after second dose on Day 14
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.
Time frame: 3 hours after second dose on Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.