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POST CATARACT SURGERY DRY EYE DISEASE

11 de agosto de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

33

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Gautier LALEVEE
  • Número de teléfono: +33 7 85 89 31 39
  • Correo electrónico: g.lalevee@noxelis.com

Ubicaciones de estudio

    • Spain
      • Alicante, Spain, España, 03001
        • Oftalvist
        • Contacto:
          • TANA RIVERO
      • Valladolid, Spain, España, 47011

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Severe ocular symptoms
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intra-Ocular Pressure (IOP)
Periodo de tiempo: 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
Periodo de tiempo: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global tolerance score evaluated by the patient
Periodo de tiempo: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the investigator
Periodo de tiempo: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Global performance score evaluated by the patient
Periodo de tiempo: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Day 84
Patient satisfaction
Periodo de tiempo: Day 28 and Day 84
Questionnaire
Day 28 and Day 84
Adverse event
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de julio de 2026

Publicado por primera vez (Actual)

20 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 22E3860 / 26-0025-U5

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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