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

NCT05002036 | Completed Phase 4

• 1 other identifier: OCU-OS-003/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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, 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).

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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

  Changes occurring between Day 1 vs Week 1 and Week 4

• Ocular Surface Disease Index (OSDI)

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

  Changes occurring between Day 1 vs Week 1 and Week 4

Secondary Outcomes (4)

• Number of patients with TBUT of 5 sec or less

  Changes occurring between Day 1 vs Week 1 and Week 4

• Number of patients with corneal epithelial staining

  Changes occurring between Day 1 vs Week 1 and Week 4

• Judgement of quality of study medications

  Week 1, Week 4

• Conjunctival hyperemia

  Changes occurring between Day 1 vs Week 1 and Week 4

Study Arms (2)

HA-GB

ACTIVE COMPARATOR

eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)

Device: Trium eyedrops

No treatment

NO INTERVENTION

no treatment for iatrogenic dry-eye

Interventions

Trium eyedrops DEVICE

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

HA-GB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

University of Milano

Milan, 20142, Italy

Location

Related Publications (1)

• 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.

  PMID: 35442771 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 12, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)