Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)
24. juni 2022 oppdatert 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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Dothan, Alabama, Forente stater, 36301
- Trinity Research Group /ID# 243541
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Arizona Eye Center /ID# 243897
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California
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Glendale, California, Forente stater, 91204-2500
- Global Research Management /ID# 243544
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Inglewood, California, Forente stater, 90301
- United Medical Research Institute /ID# 243531
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Newport Beach, California, Forente stater, 92663-3600
- Salvay Vision /ID# 243828
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Newport Beach, California, Forente stater, 92663-3637
- The Eye Research Foundation /ID# 243524
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Sacramento, California, Forente stater, 95815
- Sacramento Eye Consultants /ID# 243538
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Florida
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Crystal River, Florida, Forente stater, 34429
- Nature Coast Clinical Research - Crystal River /ID# 243519
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Delray Beach, Florida, Forente stater, 33484
- Segal Drug Trials, Inc /ID# 243521
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Fort Myers, Florida, Forente stater, 33901
- Eye Associates of Fort Meyers /ID# 243545
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Jacksonville, Florida, Forente stater, 32204
- Levenson Eye Associates Inc. /ID# 243532
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Georgia
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Atlanta, Georgia, Forente stater, 30322-1013
- Emory University /ID# 243534
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Morrow, Georgia, Forente stater, 30260-4180
- Clayton Eye Clinical Research, LLC /ID# 243530
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Roswell, Georgia, Forente stater, 30076
- Coastal Research Associates /ID# 243525
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Kansas
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Pittsburg, Kansas, Forente stater, 66762-2620
- Kannarr Eye Care /ID# 243542
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017-3415
- Cincinnati Eye Institute- Edgewood /ID# 243810
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Louisville, Kentucky, Forente stater, 40206-1738
- The Eye Care Institute /ID# 243588
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Michigan
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Fraser, Michigan, Forente stater, 48026
- Fraser Eye Center /ID# 244038
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Missouri
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Kansas City, Missouri, Forente stater, 64034
- Silverstein Eye Centers /ID# 243546
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New Jersey
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Dover, New Jersey, Forente stater, 07801-1629
- Eye Associates of North Jersey /ID# 243913
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South Orange, New Jersey, Forente stater, 07079-1855
- Northern New Jersey Eye Institute PA /ID# 243522
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New York
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Rochester, New York, Forente stater, 14618-2616
- Rochester Ophthalmological Group PC /ID# 243539
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Ohio
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Powell, Ohio, Forente stater, 43065
- EyeCare Professionals Inc /ID# 243938
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Pennsylvania
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Cranberry Township, Pennsylvania, Forente stater, 16066
- Scott and Christie and Associates /ID# 243548
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Tennessee
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Maryville, Tennessee, Forente stater, 37805
- University Eye Surgeons /ID# 243926
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Smyrna, Tennessee, Forente stater, 37167
- Advancing Vision Research /ID# 243529
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Texas
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Dallas, Texas, Forente stater, 75243
- Key-Whitman Eye Center /ID# 243928
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San Antonio, Texas, Forente stater, 78229
- Eye associates /ID# 243526
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San Antonio, Texas, Forente stater, 78229
- Parkhurst Nuvision /ID# 244041
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Utah
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Draper, Utah, Forente stater, 84020-7133
- Hoopes, Durrie, Rivera Research /ID# 243535
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Ogden, Utah, Forente stater, 84403-2200
- Country Hills Eye Center /ID# 243520
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Saint George, Utah, Forente stater, 84790
- Southern Utah Medical Research /ID# 243931
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Experiencing Adverse Events (AEs)
Tidsramme: 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.
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Up to approximately 14 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
9. juni 2022
Primær fullføring (Forventet)
4. april 2023
Studiet fullført (Forventet)
4. april 2023
Datoer for studieregistrering
Først innsendt
23. mai 2022
Først innsendt som oppfylte QC-kriteriene
23. mai 2022
Først lagt ut (Faktiske)
26. mai 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2022
Sist bekreftet
1. juni 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M21-194
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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