Back to resultsManagement of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Trium eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion criteria were:
- At least 18 years old Cataract requiring surgery
- TBUT of 7" or more in both eyes.
Exclusion criteria were:
- 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.
Sites / Locations
- University of Milano
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HA-GB
No treatment
Arm Description
eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)
no treatment for iatrogenic dry-eye
Outcomes
Primary Outcome Measures
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
Ocular Surface Disease Index (OSDI)
A score ranging from 0 to 100 calculated by means of a questionnaire
Secondary Outcome Measures
Number of patients with TBUT of 5 sec or less
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
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05002036
Brief Title
Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HA-GB
Arm Type
Active Comparator
Arm Description
eyedrop containing hyaluronic acid and gingko biloba (Trium eyedrops, Sooft srl)
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
no treatment for iatrogenic dry-eye
Intervention Type
Device
Intervention Name(s)
Trium eyedrops
Intervention Description
given three times daily from day 1 after surgery to end of Week 4
Primary Outcome Measure Information:
Title
Tear Break-up time (TBUT), seconds
Description
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
Time Frame
Changes occurring between Day 1 vs Week 1 and Week 4
Title
Ocular Surface Disease Index (OSDI)
Description
A score ranging from 0 to 100 calculated by means of a questionnaire
Time Frame
Changes occurring between Day 1 vs Week 1 and Week 4
Secondary Outcome Measure Information:
Title
Number of patients with TBUT of 5 sec or less
Time Frame
Changes occurring between Day 1 vs Week 1 and Week 4
Title
Number of patients with corneal epithelial staining
Description
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
Time Frame
Changes occurring between Day 1 vs Week 1 and Week 4
Title
Judgement of quality of study medications
Description
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)
Time Frame
Week 1, Week 4
Title
Conjunctival hyperemia
Description
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)
Time Frame
Changes occurring between Day 1 vs Week 1 and Week 4
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria were:
At least 18 years old Cataract requiring surgery
TBUT of 7" or more in both eyes.
Exclusion criteria were:
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.
Facility Information:
Facility Name
University of Milano
City
Milano
ZIP/Postal Code
20142
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35442771
Citation
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.
Results Reference
derived
Learn more about this trial
Management of Dry Eye Disease After Cataract Surgery With Topical Hyaluronic Acid and Gingko Biloba
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