Virgo: 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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: AGN-190584 One drop bilaterally twice daily for 14 days. |
Drug: AGN-190584
Ocular drops
Other Names:
|
Placebo Comparator: Vehicle One drop bilaterally twice daily for 14 days. |
Drug: Vehicle
Ocular drops
|
Outcome Measures
Primary Outcome Measures
- 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 [Day 14]
Both near vision and distance vision are measured to evaluate the effect of AGN-190584.
Secondary Outcome Measures
- 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 [Day 14]
Both near vision and distance vision are measured to evaluate the effect of AGN-190584.
- 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 [Day 14]
Both near vision and distance vision are measured to evaluate the effect of AGN-190584.
- 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 [Day 14]
Both near vision and distance vision are measured to evaluate the effect of AGN-190584.
Eligibility Criteria
Criteria
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.
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Diagnosis of any type of glaucoma or ocular hypertension.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Empire Eye and Laser /ID# 231433 | Bakersfield | California | United States | 93309-0637 |
2 | Global Research Management /ID# 231300 | Glendale | California | United States | 91204-2500 |
3 | United Medical Research Institute /ID# 233982 | Inglewood | California | United States | 90301 |
4 | North Valley Eye Medical Group, Inc. /ID# 231270 | Mission Hills | California | United States | 91345-1200 |
5 | The Eye Research Foundation /ID# 231274 | Newport Beach | California | United States | 92663-3637 |
6 | Martel Eye Medical Group /ID# 231332 | Rancho Cordova | California | United States | 95670-2968 |
7 | Nature Coast Clinical Research - Crystal River /ID# 231298 | Crystal River | Florida | United States | 34429 |
8 | Bruce Segal, MD /ID# 231413 | Delray Beach | Florida | United States | 33484-6540 |
9 | Clayton Eye Clinical Research, LLC /ID# 231243 | Morrow | Georgia | United States | 30260-4180 |
10 | Jacksoneye, SC /ID# 231374 | Lake Villa | Illinois | United States | 60046-8563 |
11 | Price Vision Group /ID# 231261 | Indianapolis | Indiana | United States | 46260-5381 |
12 | Kannarr Eye Care /ID# 231363 | Pittsburg | Kansas | United States | 66762-2620 |
13 | Cincinnati Eye Institute- Edgewood /ID# 231356 | Edgewood | Kentucky | United States | 41017-3415 |
14 | The Eye Care Institute /ID# 231275 | Louisville | Kentucky | United States | 40206-1738 |
15 | Rochester Ophthalmological Group PC /ID# 231371 | Rochester | New York | United States | 14618-2616 |
16 | Southern College of Optometry /ID# 231325 | Memphis | Tennessee | United States | 38104-2211 |
17 | Total Eye Care, PA /ID# 231245 | Memphis | Tennessee | United States | 38119-5745 |
18 | Advancing Vision Research /ID# 231244 | Smyrna | Tennessee | United States | 37167 |
19 | Hill Country Eye Center /ID# 231293 | Cedar Park | Texas | United States | 78613-7651 |
20 | The Cataract & Glaucoma Center /ID# 231292 | El Paso | Texas | United States | 79902-1444 |
21 | Eye associates /ID# 231262 | San Antonio | Texas | United States | 78229 |
22 | Hoopes, Durrie, Rivera Research /ID# 231273 | Draper | Utah | United States | 84020-7133 |
23 | Country Hills Eye Center /ID# 231414 | Ogden | Utah | United States | 84403-2200 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: ALLERGAN INC., Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M21-195