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POST CATARACT SURGERY DRY EYE DISEASE

11 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

33

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Spain
      • Alicante, Spain, Espanha, 03001
        • Oftalvist
        • Contato:
          • TANA RIVERO
      • Valladolid, Spain, Espanha, 47011

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Severe ocular symptoms
Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de julho de 2026

Primeira postagem (Real)

20 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 22E3860 / 26-0025-U5

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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