NOX-01
Device1 drop per eye, four times per day, in the operated eye
NCT Number: NCT07715266
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.
Trial opening soon.
Get Notified18 year–78 year
All sexes
Interventional
Not applicable
Oftalvist, Alicante, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In terms of population
In terms of associated pathology
1 drop per eye, four times per day, in the operated eye
Time frame: Day 1, Day 7, Day 28 and Day 84
Tolerance of NOX-01 : Proportion of subject with at least one severe symptom.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 7, Day 28, Day 84
Visual Analog Scale Symptom Index : from 0% to 100% (worse)
Time frame: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 84
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 28 and Day 84
Questionnaire
Time frame: 7 day before surgery, Day 1, Day 7, Day 28, Day 84
Adverse event collection
Contact information is provided by the study sponsor or research team.
NOXELIS
Industry
PILOT STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF A NEW MEDICAL DEVICE ON POST CATARACT SURGERY DRY EYE DISEASE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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