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POST CATARACT SURGERY DRY EYE DISEASE

2026年8月11日 更新者:NOXELIS

PILOT STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF A NEW MEDICAL DEVICE ON POST CATARACT SURGERY DRY EYE DISEASE

Cataract surgery is one of the most frequent and successful interventions currently undertaken in medicine. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms, such as irritation, pain, dryness, burning sensation, and foreign body sensation. Dry eye disease (DED) is a common postoperative symptom, with a prevalence fluctuating from 9.8% to 34% depending on the studies. The onset, or the worsening, of DED signs and symptoms usually occurs in the first postoperative week and may last for months affecting the satisfaction and quality of life of the patient. The reasons of dry eye development after cataract surgery include thermal and light toxicity from the microscope, corneal epithelial damage, repeated drying and irrigation of ocular surface during operation, sterilization of conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal incision, use of topical anaesthetics, and preservatives in topical eye drops. The mainstay of post-cataract surgery DED prevention and management is the treatment with non-preserved artificial tears, which has shown good results in terms of the reduction in postoperative DED signs and symptoms in previous clinical studies.

NOX-01 Ocular Drops is a medical device not already CE-marked. It is a preservative-free ophthalmic lubricant solution intended to be used in cases of moderate to severe dry eye in adults, regardless of gender. NOX-01 is a biomimetic emulsion which lubricates and protects the corneal surface, limiting the inflammation due to dry eye and stabilizing the tear film.

The primary objective of this pilot and pre-market study is to assess the tolerance of NOX-01 on eye dryness syndrome before and after a cataract surgery, in patients with pre-existing mild to moderate DED, during 84 days of use (12 weeks). The performance of the product, used 4 times per day, in improving signs of symptoms of DED, will also be assessed before and after cataract surgery, as well as subject and investigator satisfaction.

調査の概要

状態

まだ募集していません

介入・治療

研究の種類

介入

入学 (推定)

33

段階

  • 適用できない

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

研究場所

    • Spain
      • Alicante、Spain、スペイン、03001
        • Oftalvist
        • コンタクト:
          • TANA RIVERO
      • Valladolid、Spain、スペイン、47011

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

Inclusion Criteria:

  • 2. Age: > 18 years and less than 78 years old. 3. Subject who requires a unilateral cataract surgery (phacoemulsification and intra ocular lens implantation) or bilateral cataract surgery with delay of maximum 4 days between two eyes operation.

    4. Subject with mild to moderate dry eye at the pre-operative visit with the following scores:

    • OSDI (Ocular Surface Disease Index) ≥ 13 and ≤ 32
    • Schirmer test in the operated eye ≥ 5 mm/5min and ≤ 15 mm/5min And/or
    • Non-invasive break-up time (NIBUT) in the operated eye: sum of 3 measurement ≥ 5 sec and ≤ 15 sec 5. Patient who did not use artificial tears 1 week before the screening visit. 6. Patient having given freely and expressly his informed consent. 7. Patient psychologically able to understand the study related information and to give a written informed consent.

      8. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion Criteria:

In terms of population

  1. Pregnant or nursing woman or planning a pregnancy during the study.
  2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
  3. Subject in a social or sanitary establishment.
  4. Subject suspected to be non-compliant according to the investigator's judgment.
  5. Patient using contact lens during screening period and the entire study (even if prescribed by the investigator after surgery).

    In terms of associated pathology

  6. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
  7. Subject with severe eye dryness
  8. Patient with palpebral malposition with a tendency to incomplete blinking +/- scleral show
  9. Patient with general pathologies that can cause dry eye syndrome like: thyroid disorder, cutaneous rosacea, acne and/or iatrogenic effects of isotretinoin treatment.
  10. Presence of ocular comorbidities such as glaucoma, uveitis or cystoid macular oedema.
  11. Neuropathic causes of dry eye ( long-standing contact lens wearing, previous ocular herpes infections)
  12. Past or active ocular surface diseases (any corneal disease, cicatricial conjunctivitis, ocular surface burns, keratinization of the eyelid margin, Sjogren syndrome, corneal trauma)
  13. Ocular or general factors predisposing the patient to an increased risk for intraoperative complications, according to investigator's evaluation
  14. Know hypersensitivity to any component of the study product Relating to previous or ongoing treatment
  15. Subject with other ocular surgery in the 12 previous months.
  16. Subject with lid surgery in the 3 previous months
  17. Subject who received systemic non-steroidal anti-inflammatory drugs, immunosuppressants, corticoids or any medication that could interfere with lacrimal function during the 3 weeks prior to the study.
  18. Subject who received topical antibiotics, topical NSAIDs, topical steroid or topical cyclosporine in either eye in the past month.

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:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:NOX-01 Treatment
1 drop per eye, four times per day, in the operated eye
1 drop per eye, four times per day, in the operated eye

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
Severe ocular symptoms
時間枠:Day 1, Day 7, Day 28 and Day 84
Tolerance of NOX-01 : Proportion of subject with at least one severe symptom.
Day 1, Day 7, Day 28 and Day 84

二次結果の測定

結果測定
メジャーの説明
時間枠
Intra-Ocular Pressure (IOP)
時間枠:7 day before surgery, Day 1, Day 84
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye
7 day before surgery, Day 1, Day 84
Global tolerance score evaluated by the investigator
時間枠:Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global tolerance score evaluated by the patient
時間枠:Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the investigator
時間枠:Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the patient
時間枠:Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Patient satisfaction
時間枠:Day 28 and Day 84
Questionnaire
Day 28 and Day 84
Adverse event
時間枠:7 day before surgery, Day 1, Day 7, Day 28, Day 84
Adverse event collection
7 day before surgery, Day 1, Day 7, Day 28, Day 84
Conjunctival hyperaemia using the McMonnies photographic scale
時間枠:7 day before surgery, Day 1, Day 7, Day 28 and D84

Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye.

Scale from 0 to 5 (worse)

7 day before surgery, Day 1, Day 7, Day 28 and D84
Non-invasive film Break-Up Time (NIBUT)
時間枠:7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye The specular image of a pattern projected onto the tear film, is examined with a corneal topographer. The time taken for the image to degrade, after the last blink, is the NIBUT, expressed in seconds. Each site will evaluate NIBUT according to their own device and procedure (Topcon CA-800 Catalog, Atlas 9000, Pentacam HD, Atlas 500 or Pentacam AXL Wave). The NIBUT will be assessed three times and the sum of these three measurements will be calculated.
7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Schirmer test result
時間枠:7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye The results are expressed in mm/5min
7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Cornea and conjunctiva staining (Oxford score)
時間枠:7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye Scale from 1 to 15 (worse)
7 day before surgery, Day 1, Day 7, Day 28 and Day 84
OSDI score
時間枠:7 day before surgery, D1, Day 7, Day 28 and Day 84
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point for the following parameters, in the first operated eye Scale from 0 to 100 (worse)
7 day before surgery, D1, Day 7, Day 28 and Day 84
Epithelial Thickening Mapping : Total pachymetry (total thickness of the cornea)
時間枠:7 day before surgery, Day 1, Day 7, Day 28
Change from baseline before cataract surgery (Day-7) and from baseline after cataract surgery (Day1) at each applicable time point, in the first operated eye Express in micrometer
7 day before surgery, Day 1, Day 7, Day 28
Symptoms evaluated by the patient using a VAS
時間枠:Day 7, Day 28, Day 84
Visual Analog Scale Symptom Index : from 0% to 100% (worse)
Day 7, Day 28, Day 84

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

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5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月15日

最初の投稿 (実際)

2026年7月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月13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11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 22E3860 / 26-0025-U5

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?

いいえ

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米国FDA規制医薬品の研究

いいえ

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いいえ

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