Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)
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.
調査の概要
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Dothan、Alabama、アメリカ、36301
- Trinity Research Group /ID# 243541
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Arizona
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Chandler、Arizona、アメリカ、85224
- Arizona Eye Center /ID# 243897
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California
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Glendale、California、アメリカ、91204-2500
- Global Research Management /ID# 243544
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Inglewood、California、アメリカ、90301
- United Medical Research Institute /ID# 243531
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Newport Beach、California、アメリカ、92663-3600
- Salvay Vision /ID# 243828
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Newport Beach、California、アメリカ、92663-3637
- The Eye Research Foundation /ID# 243524
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Sacramento、California、アメリカ、95815
- Sacramento Eye Consultants /ID# 243538
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Florida
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Crystal River、Florida、アメリカ、34429
- Nature Coast Clinical Research - Crystal River /ID# 243519
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Delray Beach、Florida、アメリカ、33484
- Segal Drug Trials, Inc /ID# 243521
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Fort Myers、Florida、アメリカ、33901
- Eye Associates of Fort Meyers /ID# 243545
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Jacksonville、Florida、アメリカ、32204
- Levenson Eye Associates Inc. /ID# 243532
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Georgia
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Atlanta、Georgia、アメリカ、30322-1013
- Emory University /ID# 243534
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Morrow、Georgia、アメリカ、30260-4180
- Clayton Eye Clinical Research, LLC /ID# 243530
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Roswell、Georgia、アメリカ、30076
- Coastal Research Associates /ID# 243525
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Kansas
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Pittsburg、Kansas、アメリカ、66762-2620
- Kannarr Eye Care /ID# 243542
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Kentucky
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Edgewood、Kentucky、アメリカ、41017-3415
- Cincinnati Eye Institute- Edgewood /ID# 243810
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Louisville、Kentucky、アメリカ、40206-1738
- The Eye Care Institute /ID# 243588
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Michigan
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Fraser、Michigan、アメリカ、48026
- Fraser Eye Center /ID# 244038
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Missouri
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Kansas City、Missouri、アメリカ、64034
- Silverstein Eye Centers /ID# 243546
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New Jersey
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Dover、New Jersey、アメリカ、07801-1629
- Eye Associates of North Jersey /ID# 243913
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South Orange、New Jersey、アメリカ、07079-1855
- Northern New Jersey Eye Institute PA /ID# 243522
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New York
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Rochester、New York、アメリカ、14618-2616
- Rochester Ophthalmological Group PC /ID# 243539
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Ohio
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Powell、Ohio、アメリカ、43065
- EyeCare Professionals Inc /ID# 243938
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Pennsylvania
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Cranberry Township、Pennsylvania、アメリカ、16066
- Scott and Christie and Associates /ID# 243548
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Tennessee
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Maryville、Tennessee、アメリカ、37805
- University Eye Surgeons /ID# 243926
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Smyrna、Tennessee、アメリカ、37167
- Advancing Vision Research /ID# 243529
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Texas
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Dallas、Texas、アメリカ、75243
- Key-Whitman Eye Center /ID# 243928
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San Antonio、Texas、アメリカ、78229
- Eye associates /ID# 243526
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San Antonio、Texas、アメリカ、78229
- Parkhurst Nuvision /ID# 244041
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Utah
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Draper、Utah、アメリカ、84020-7133
- Hoopes, Durrie, Rivera Research /ID# 243535
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Ogden、Utah、アメリカ、84403-2200
- Country Hills Eye Center /ID# 243520
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Saint George、Utah、アメリカ、84790
- Southern Utah Medical Research /ID# 243931
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- M21-194
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。