Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)
24 juni 2022 uppdaterad av: Allergan
A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia
Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.
AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.
Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
-
Dothan, Alabama, Förenta staterna, 36301
- Trinity Research Group /ID# 243541
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Arizona
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Chandler, Arizona, Förenta staterna, 85224
- Arizona Eye Center /ID# 243897
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California
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Glendale, California, Förenta staterna, 91204-2500
- Global Research Management /ID# 243544
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Inglewood, California, Förenta staterna, 90301
- United Medical Research Institute /ID# 243531
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Newport Beach, California, Förenta staterna, 92663-3600
- Salvay Vision /ID# 243828
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Newport Beach, California, Förenta staterna, 92663-3637
- The Eye Research Foundation /ID# 243524
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Sacramento, California, Förenta staterna, 95815
- Sacramento Eye Consultants /ID# 243538
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Florida
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Crystal River, Florida, Förenta staterna, 34429
- Nature Coast Clinical Research - Crystal River /ID# 243519
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Delray Beach, Florida, Förenta staterna, 33484
- Segal Drug Trials, Inc /ID# 243521
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Fort Myers, Florida, Förenta staterna, 33901
- Eye Associates of Fort Meyers /ID# 243545
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Jacksonville, Florida, Förenta staterna, 32204
- Levenson Eye Associates Inc. /ID# 243532
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322-1013
- Emory University /ID# 243534
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Morrow, Georgia, Förenta staterna, 30260-4180
- Clayton Eye Clinical Research, LLC /ID# 243530
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Roswell, Georgia, Förenta staterna, 30076
- Coastal Research Associates /ID# 243525
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Kansas
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Pittsburg, Kansas, Förenta staterna, 66762-2620
- Kannarr Eye Care /ID# 243542
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Kentucky
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Edgewood, Kentucky, Förenta staterna, 41017-3415
- Cincinnati Eye Institute- Edgewood /ID# 243810
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Louisville, Kentucky, Förenta staterna, 40206-1738
- The Eye Care Institute /ID# 243588
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Michigan
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Fraser, Michigan, Förenta staterna, 48026
- Fraser Eye Center /ID# 244038
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Missouri
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Kansas City, Missouri, Förenta staterna, 64034
- Silverstein Eye Centers /ID# 243546
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New Jersey
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Dover, New Jersey, Förenta staterna, 07801-1629
- Eye Associates of North Jersey /ID# 243913
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South Orange, New Jersey, Förenta staterna, 07079-1855
- Northern New Jersey Eye Institute PA /ID# 243522
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New York
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Rochester, New York, Förenta staterna, 14618-2616
- Rochester Ophthalmological Group PC /ID# 243539
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Ohio
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Powell, Ohio, Förenta staterna, 43065
- EyeCare Professionals Inc /ID# 243938
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Pennsylvania
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Cranberry Township, Pennsylvania, Förenta staterna, 16066
- Scott and Christie and Associates /ID# 243548
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Tennessee
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Maryville, Tennessee, Förenta staterna, 37805
- University Eye Surgeons /ID# 243926
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Smyrna, Tennessee, Förenta staterna, 37167
- Advancing Vision Research /ID# 243529
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Texas
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Dallas, Texas, Förenta staterna, 75243
- Key-Whitman Eye Center /ID# 243928
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San Antonio, Texas, Förenta staterna, 78229
- Eye associates /ID# 243526
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San Antonio, Texas, Förenta staterna, 78229
- Parkhurst Nuvision /ID# 244041
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Utah
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Draper, Utah, Förenta staterna, 84020-7133
- Hoopes, Durrie, Rivera Research /ID# 243535
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Ogden, Utah, Förenta staterna, 84403-2200
- Country Hills Eye Center /ID# 243520
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Saint George, Utah, Förenta staterna, 84790
- Southern Utah Medical Research /ID# 243931
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
- If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
- Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score >= 3) on at least 1 question on 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Questions 5 to 7 in the main questionnaire or Near Vision Subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions at the screening visit.
- Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
- Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.
Exclusion Criteria:
- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: AGN-190584
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
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Eye drops
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Placebo-jämförare: Vehicle
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
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Eye drops
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Tidsram: Up to approximately 14 days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study.
|
Up to approximately 14 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
9 juni 2022
Primärt slutförande (Förväntat)
4 april 2023
Avslutad studie (Förväntat)
4 april 2023
Studieregistreringsdatum
Först inskickad
23 maj 2022
Först inskickad som uppfyllde QC-kriterierna
23 maj 2022
Första postat (Faktisk)
26 maj 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M21-194
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission.
This includes requests for clinical trial data for unlicensed products and indications.
Tidsram för IPD-delning
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Kriterier för IPD Sharing Access
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement.
Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication.
For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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