An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults
2026年8月26日 更新者：Alcon Research
A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks.
Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office.
Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation.
Eye redness will be assessed before and after instillation at prespecified timepoints.
研究の種類
介入
入学 (推定)
178
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Alcon Call Center
- 電話番号：1-888-451-3937
- メール：alcon.medinfo@alcon.com
研究場所
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Texas
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Fort Worth、Texas、アメリカ、76134
- Contact Alcon Call Center for Trial Locations
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Key Inclusion Criteria:
- Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
- Willing and able to follow all instructions and attend all study visits.
- History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
- Baseline ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
- Ocular surgical interventions within 6 months prior to Visit 1 or during the study.
- Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study parameters.
- Use of prohibited medications, devices, or treatments as specified in the protocol.
- Out of range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
- Abnormal intraocular pressure.
- Other protocol-defined exclusion criteria may apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Vehicle
One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56.
On the day of Day 56, subjects will receive the last dose in-office.
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Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
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実験的：Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56.
On the day of Day 56, subjects will receive the last dose in-office.
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Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
他の名前：
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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 |
|---|---|---|
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Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5.
Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
This is a co-primary endpoint.
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Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
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Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5.
Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
This is a co-primary endpoint.
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Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5.
Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
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Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
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Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5.
Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
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Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
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Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5.
Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
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Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
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Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on Day 1
時間枠：Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
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Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness).
The 30-second score will be compared to the baseline score.
The number of subjects with improvements as prespecified in the protocol will be reported.
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Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Clinical Trial Lead, Pharma、Alcon Research, LLC
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
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。