New eye drop aims to soothe dryness after cataract surgery

NCT ID NCT07715266

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 20, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This pilot study tests a new preservative-free eye drop called NOX-01 in people with mild to moderate dry eye who are having cataract surgery. The drop is designed to lubricate and protect the eye surface, potentially reducing the dry eye symptoms that often occur after surgery. Researchers will monitor safety and how well the drop improves signs and symptoms of dry eye over 12 weeks of use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a preservative-free biomimetic emulsion eye drop called NOX-01
What this could lead to
If successful, NOX-01 could offer a new option for preventing or easing dry eye discomfort after cataract surgery, improving patient satisfaction and recovery.
What could go wrong
This is a small pilot study with only 33 participants, so results may not apply to everyone. The device is not yet CE-marked, and its safety and effectiveness are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 78 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • IOBA

    Valladolid, Spain, 47011, Spain

  • Oftalvist

    Alicante, Spain, 03001, Spain

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