Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease (INFLIXIDRY)
Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.
Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers.
This study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.
調査の概要
詳細な説明
Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers.
This study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Gustavo Ortiz-Morales, MD
- 電話番号：5554421700
- メール：dr.gortizmor@gmail.com
研究場所
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Mexico City
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Mexico City、Mexico City、メキシコ、06800
- Instituto de Oftalmología Conde de Valenciana
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参加基準
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
説明
Inclusion Criteria:
- Adult patients (≥ 18 years).
- Confirmed diagnosis of primary or secondary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
- On stable systemic immunomodulatory therapy (non-biologic) for at least 12 weeks, with no planned changes during the study (see section 14.1 if there are concerns about confounding variables).
- Negative chest X-ray or Interferon-Gamma Release Assays (IGRA).
- Diagnosis of severe dry eye, defined by meeting all of the following criteria in at least one eye at study entry:
- OSS (SICCA 0-12) ≥ 6 in at least one eye.
- OSDI ≥ 33 (severe symptoms).
- Symptoms: OSDI score ≥ 33.
- Signs: Ocular Staining Score (OSS, SICCA) ≥ 6.
- Ability to understand and sign informed consent and to comply with study procedures and treatment administration.
Exclusion Criteria:
- Current use of topical corticosteroids or topical immunomodulators (cyclosporine, lifitegrast, tacrolimus, autologous serum) within 30 days prior to enrollment.
- Current or recent use (< 3 months) of punctal plugs.
- Active ocular infection (bacterial, viral, fungal) or recent history of herpetic keratitis.
- Ocular or eyelid surgery within the past 6 months.
- Use of contact lenses during the study period.
- Known allergy or hypersensitivity to infliximab, murine proteins, or any component of the formulation (including CMC).
- Coexisting ocular conditions that may interfere with dry eye evaluation (e.g., active ocular cicatricial pemphigoid, active ocular graft-versus-host disease, uncontrolled glaucoma, significant corneal dystrophy).
- Systemic conditions considered contraindications to infliximab exposure, including: active systemic infection, untreated active or latent tuberculosis, history of demyelinating disease, moderate to severe congestive heart failure (NYHA Class III/IV), or history of malignancy within the past 5 years.
- Use of systemic biologic agents within the past 6 months (12 months for systemic anti-TNF-α therapy).
- Pregnancy, breastfeeding, or intention to become pregnant during the study.
- Participation in another clinical trial with an investigational drug within the past 30 days.
- Ability to understand and sign informed consent and to comply with study procedures and treatment administration.
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：トリプル
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：Infliximab group
Arm A: Infliximab Group (Intervention) Participants assigned to this group will receive: Topical infliximab 1 mg/mL (0.1%) in CMC 1%, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) This group evaluates whether adding infliximab to standard therapy improves symptoms and ocular surface inflammation. |
It uses topical infliximab at 1 mg/mL (0.1%) formulated in preservative-free 1% carboxymethylcellulose (CMC), administered as 1 drop in each eye four times daily for 6 weeks.
The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.
他の名前：
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アクティブコンパレータ：Vehicle group
Participants assigned to this group will receive: Vehicle (CMC 1%) eye drops without infliximab, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) Preservative-free artificial tears as needed (rescue treatment) This group serves as the control, allowing comparison against standard treatment plus vehicle. |
The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.
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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 in Ocular Surface Disease Index (OSDI)
時間枠：6 weeks.
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Measures patient-reported symptoms.
Outcome is assesed from baseline to 6 weeks.
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6 weeks.
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協力者と研究者
捜査官
- 主任研究者：Enrique Graue-Hernandez, MD, MSc、Instituto de Oftalmologia Fundacion Conde de Valenciana
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CEI-2025-11-02
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?
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