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POST CATARACT SURGERY DRY EYE DISEASE

2026년 8월 11일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

개입 / 치료

연구 유형

중재적

등록 (추정된)

33

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Spain
      • Alicante, Spain, 스페인, 03001
        • Oftalvist
        • 연락하다:
          • TANA RIVERO
      • Valladolid, Spain, 스페인, 47011

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Severe ocular symptoms
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Intra-Ocular Pressure (IOP)
기간: 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
기간: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global tolerance score evaluated by the patient
기간: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the investigator
기간: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the patient
기간: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Patient satisfaction
기간: Day 28 and Day 84
Questionnaire
Day 28 and Day 84
Adverse event
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: Day 7, Day 28, Day 84
Visual Analog Scale Symptom Index : from 0% to 100% (worse)
Day 7, Day 28, Day 84

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 5월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2026년 7월 8일

QC 기준을 충족하는 최초 제출

2026년 7월 15일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 11일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 22E3860 / 26-0025-U5

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

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