Dry Eye Disease (DED)NCT07715266
POST CATARACT SURGERY DRY EYE DISEASE
A study testing NOX-01 in people with Dry Eye Disease (DED) and Cataract Surgery, run by NOXELIS at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Dry Eye Disease (DED), Cataract Surgery
- What is being tested?
- NOX-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Oftalvist
Alicante, Spain, 03001
TANA RIVERO
IOBA
Valladolid, Spain, 47011
MALDONADO LOPEZ, maldonado@uva.es
About this study
Official title: 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.
- Conditions
- Dry Eye Disease (DED), Cataract Surgery
- Being tested
- NOX-01
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX-01Device
1 drop per eye, four times per day, in the operated eye
| Study group | Role | What they receive |
|---|---|---|
| NOX-01 Treatment | Experimental | 1 drop per eye, four times per day, in the operated eye Receives: Device: NOX-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe ocular symptoms
Tolerance of NOX-01 : Proportion of subject with at least one severe symptom.
Measured: Day 1, Day 7, Day 28 and Day 84
Secondary outcomes (14)
Conjunctival hyperaemia using the McMonnies photographic scale
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)
Measured: 7 day before surgery, Day 1, Day 7, Day 28 and D84
Non-invasive film Break-Up Time (NIBUT)
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.
Measured: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Schirmer test result
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
Measured: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84
Cornea and conjunctiva staining (Oxford score)
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)
Measured: 7 day before surgery, Day 1, Day 7, Day 28 and Day 84
OSDI score
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)
Measured: 7 day before surgery, D1, Day 7, Day 28 and Day 84
Epithelial Thickening Mapping : Total pachymetry (total thickness of the cornea)
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
Measured: 7 day before surgery, Day 1, Day 7, Day 28
Intra-Ocular Pressure (IOP)
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
Measured: 7 day before surgery, Day 1, Day 84
Symptoms evaluated by the patient using a VAS
Visual Analog Scale Symptom Index : from 0% to 100% (worse)
Measured: Day 7, Day 28, Day 84
Global tolerance score evaluated by the investigator
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 84
Global tolerance score evaluated by the patient
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 84
Global performance score evaluated by the investigator
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 84
Global performance score evaluated by the patient
On a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Measured: Day 84
Patient satisfaction
Questionnaire
Measured: Day 28 and Day 84
Adverse event
Adverse event collection
Measured: 7 day before surgery, Day 1, Day 7, Day 28, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NOXELIS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715266
- Sponsor's protocol ID
- 22E3860 / 26-0025-U5
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF A NEW MEDICAL DEVICE ON POST CATARACT SURGERY DRY EYE DISEASE
- ClinicalTrials.gov ID
- NCT07715266
- Acronym / sponsor ID
- 22E3860 / 26-0025-U5
- Conditions
- Dry Eye Disease (DED), Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- NOXELISIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOX-01 Treatment | Experimental | Device: NOX-011 drop per eye, four times per day, in the operated eye |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOX-011 drop per eye, four times per day, in the operated eye | Device | NOX-01 Treatment |
Primary outcome
Severe ocular symptoms
Time frame: Day 1, Day 7, Day 28 and Day 84
Tolerance of NOX-01 : Proportion of subject with at least one severe symptom.
14 secondary outcomes
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
Patient satisfaction
Time frame: Day 28 and Day 84
Adverse event
Time frame: 7 day before surgery, Day 1, Day 7, Day 28, Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOX-01 in people with Dry Eye Disease (DED) and Cataract Surgery, run by NOXELIS at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gautier LALEVEE (+33 7 85 89 31 39, g.lalevee@noxelis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe ocular symptoms (time frame: Day 1, Day 7, Day 28 and Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.