SAFETY AND PERFORMANCE OF A NEW MEDICAL DEVICE ON POST CATARACT SURGERY DRY EYE DISEASE

Official title

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

Overview

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.

Interventions

• Device NOX-01
  1 drop per eye, four times per day, in the operated eye

Primary outcome measures

• Tolerance of NOX-01 [Time frame: Day 1, Day 7, Day 28 and Day 84]

Secondary outcome measures (12)

• Conjunctival hyperaemia using the McMonnies photographic scale [Time frame: 7 day before surgery, Day 1, Day 7, Day 28 and D84]
• Non-invasive film Break-Up Time (NIBUT) [Time frame: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84]
• Schirmer test result [Time frame: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84]
• Cornea and conjunctiva staining (Oxford score) [Time frame: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84]
• OSDI score [Time frame: 7 day before surgery, D1, Day 7, Day 28 and Day 84]
• Epithelial Thickening Mapping : Total pachymetry (total thickness of the cornea) [Time frame: 7 day before surgery, Day 1, Day 7, Day 28]
• Intra-Ocular Pressure (IOP) [Time frame: 7 day before surgery, Day 1, Day 84]
• Symptoms evaluated by the patient using a VAS [Time frame: Day 7, Day 28, Day 84]
• Global tolerance score evaluated by the investigator [Time frame: Day 84]
• Global tolerance score evaluated by the patient [Time frame: Day 84]
• Global performance score evaluated by the investigator [Time frame: Day 84]
• Global performance score evaluated by the patient [Time frame: Day 84]

Eligibility criteria

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

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

In terms of associated pathology

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Oftalvist — Alicante
• IOBA — Valladolid

Identifiers

NCT: NCT07715266 · 22E3860 / 26-0025-U5

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗