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POST CATARACT SURGERY DRY EYE DISEASE

NCT07715266 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Dry Eye Disease (DED)
  • Cataract Surgery

Interventions

DEVICE

NOX-01

1 drop per eye, four times per day, in the operated eye

Sponsors & Collaborators

  • Eurofins Dermscan Pharmascan

    collaborator INDUSTRY

  • NOXELIS

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715266 on ClinicalTrials.gov