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Dry Eye SyndromesPhase 4NCT05002036

Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba

A Phase 4 study testing Trium eyedrops in people with Dry Eye Syndromes, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cataract surgery is one of the main causes of Dry Eye Disease (DED). This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery, and the impact of an eyedrop containing hyaluronic acid and gingko biloba (HA-GB, Trium free eyedrops, Sooft srl… Read more about this study

Who is it for?
Any age
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Trium eyedrops
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
1 Feb 2021to 1 May 2021
Phase
Phase 4
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • At least 18 years old Cataract requiring surgery
  • TBUT of 7" or more in both eyes.

Who cannot join

  • BUT of 6 seconds or less in one or both eyes
  • Corneal staining of grade 2 or more using Oxford scale in one or both eyes
  • Presence of corneal neuropathy (Cochet-Bonnet esthesiometry less than 50 mm) in one or both eyes
  • Contact lens wear less than 30 days before surgery
  • Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
  • Autoimmune diseases
Show all 9Show fewer
  • Past or active ocular surface diseases (any corneal disease, cicatricial conjunctivitis, ocular surface burns, keratinization of the eyelid margin, Sjogren syndrome, corneal trauma)
  • pregnant and lactating women pediatric patients or adolescents under 18 years
  • ocular or general factors predisposing the patient to an increased risk for intraoperative complications, according to investigator's evaluation. These include (but are not limited to) pseudoexfoliation capsulae, complete cataract, iridodonesis, previous eye surgery, previous eye trauma, history of complicated cataract surgery in the fellow eye, benign prostatic hyperplasia under treatment.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Milano

    Milan, 20142

Other trials in Italy

About this study

Official title: Evaluation of the Clinical Efficacy of Hyaluronic Acid and Gingko Biloba Eyedrops in the Management of Iatrogenic Dry Eye Disease Induced by Cataract Surgery

Cataract surgery is one of the main causes of Dry Eye Disease (DED). This paper aimed at evaluating the prevalence of iatrogenic DED on a population of patients without DED receiving cataract surgery, and the impact of an eyedrop containing hyaluronic acid and gingko biloba (HA-GB, Trium free eyedrops, Sooft srl, Italy).

In this phase-IV trial we enrolled 40 patients with no DED. Patients were seen at baseline, day 1, week 1 and week 4. At each visit patients received Ocular Surface Disease Index (OSDI) questionnaire, Anterior segment ophthalmoscopy with grading of conjunctival hyperemia, fluorescein tear break-up time (TBUT), grading of fluorescein corneal staining (epithelial damage); adherence and tolerability using a visual analogue scale were checked at week 1 and 4.

At day 0 patients underwent cataract surgery (2.4 mm temporal incision) and were randomized to standard postoperative care (control group) or standard postoperative care + HA-GB given three times a day for 4 weeks (HA-GB group).

Being tested
Trium eyedrops
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.

  • Trium eyedropsDevice

    given three times daily from day 1 after surgery to end of Week 4

Study groups in NCT05002036
Study groupRoleWhat they receive
HA-GBActive comparatoreyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)
Receives: Device: Trium eyedrops
No treatmentNo interventionno treatment for iatrogenic dry-eye

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tear Break-up time (TBUT), seconds

    The time (seconds) from blinking from the first break of the tear film stained with fluorescein and evaluated at the slit lamp with blue cobalt filter and 10x magnification

    Measured: Changes occurring between Day 1 vs Week 1 and Week 4

  2. Ocular Surface Disease Index (OSDI)

    A score ranging from 0 to 100 calculated by means of a questionnaire

    Measured: Changes occurring between Day 1 vs Week 1 and Week 4

Secondary outcomes (4)

  1. Number of patients with TBUT of 5 sec or less

    Measured: Changes occurring between Day 1 vs Week 1 and Week 4

  2. Number of patients with corneal epithelial staining

    Staining was evaluated at the slit lamp with fluorescein dying, blue cobalt filter and 10x magnification. Staining was graded according to the Oxford scale, ranging from 0 (no staining) to 4

    Measured: Changes occurring between Day 1 vs Week 1 and Week 4

  3. Judgement of quality of study medications

    Patients were asked to judge the quality of study medications using a Visual analogue scale. The score was converted on a scale between 0 (very bad evaluation) and 100 (very high satisfaction)

    Measured: Week 1, Week 4

  4. Conjunctival hyperemia

    Assessed using diffuse white illumination at the slit lamp with 10x magnification. Results were reported using Efron scale, ranging from 0 (normal) to 4 (severe)

    Measured: Changes occurring between Day 1 vs Week 1 and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Feb 2021
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002036
Sponsor's protocol ID
OCU-OS-003/2019
Status last verified
Jul 2021
First submitted
28 Jul 2021
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fogagnolo P, Romano D, De Ruvo V, Sabella P, Rossetti L. Clinical Efficacy of an Eyedrop Containing Hyaluronic Acid and Ginkgo Biloba in the Management of Dry Eye Disease Induced by Cataract Surgery. J Ocul Pharmacol Ther. 2022 May;38(4):305-310. doi: 10.1089/jop.2021.0123. Epub 2022 Apr 18.

    PubMed 35442771

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trium eyedrops in people with Dry Eye Syndromes, run by University of Milan at 1 site in Italy.

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Break-up time (TBUT), seconds (time frame: Changes occurring between Day 1 vs Week 1 and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05002036, which also lists 1 linked publication.

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 12 Aug 2021.

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