Clinical trial NCT06533995: The Usefulness of Visuprime in Cataract Surgery
Official title: The Performance of Visuprime in Improving Ocular Surface Homeostasis and Reducing Conjunctival Bacterial Load in Patients Receiving Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicentre, post-market, open label, randomized, placebo-controlled prospective study exploring the performance of Visuprime in improving ocular surface homeostasis and reducing conjunctival bacterial load in patients receiving cataract surgery, as an addon treatment to postoperative standard terapy. The study will consist on 3 visits: Visit 1 (day -3 from surgery), Visit 2 (day 0, surgery), and Visit 3 (day 7 from surgery). Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. At each visit all study procedures will be performed according to the clinical investigation plan requirements. Patients will be enrolled at Visit 1 and randomized with a 1:1 ratio to 2 groups:

GROUP A: patients receiving Visuprime eyedrop BID from day -3 to week 1. After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop + levofloxacin eyedrop, both given four times daily (QID) from day 0 (after surgery) to the end of the study.

GROUP B: patients receiving placebo eyedrop (the vehicle of Visuprime, i.e. isotonic buffered saline solution) BID from day -3 to week 1.

After surgery, patients will be also given standard postoperative treatment consisting on unitdose desametasone eyedrop QID + levofloxacin eyedrop QID from day 0 to the end of the study.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old patients, male and female
* Previous diagnosis of cataract requiring surgery
* Wishing to participate in the study and able to sign the ICF
* No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion Criteria:

* Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g.rheumatic disease)
* Previous participation on this study for the fellow eye
* Increased risk of complicated cataract surgery according to the investigator assessment (for example presence of dilation less than 6 mm, pupil decentration, pseudoexfoliation, areas of iris atrophy, sublussation or lussation of the lens, complete cataract, sac instability, iridodonesis, systemic disease limiting intraoperative patient cooperation)
* Coexisting corneal diseases
* Past or active conjunctivitis - any type
* Past ocular surface burns
* Keratinization of the eyelid margin
* Sjogren syndrome
* History of corneal trauma
* Pregnant and lactating women
* Inability to self-administer study medications
* Know allergic sensitivity to any of the devices ingredients, or any other type of allergy
* Participation in a clinical trial during the 3 months prior to the beginning of the study.

Primary outcomes:
measure: TBUT (Tear-Break-Up-Time)
timeFrame: V1 (Day -3 from surgery),V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: TBUT (Tear-Break-Up-Time)
timeFrame: V3-V1 (ten days) , V2-V1(three days)
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: Ocular Surface Disease Index (OSDI)
timeFrame: V3-V1(ten days), V2-V1(three days)
measure: Instantaneous Non-Invasive Break-up time (iNIBUT)
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: Instantaneous Non-Invasive Break-up time (iNIBUT)
timeFrame: V3-V1(ten days), V2-V1(three days)
measure: mean Non-Invasive Break-up time (mNIBUT)
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: mNIBUT (mean NIBUT)
timeFrame: V3-V1(ten days), V2-V1(three days)
measure: Tear meniscus height (TMH)
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: Tear meniscus height (TMH)
timeFrame: V3-V1 (ten days), V2-V1(three days)
measure: Conjunctival hyperemia
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: Corneal staining
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: Bacterial Load
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: VAS (Visual Analogue Scale)
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
measure: 5-point Likert Scale
timeFrame: V1 (Day -3 from surgery), V2 (Day 0, surgery), V3 (Day 7 after surgery)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Casilino
state: RM
city: Rome
country: Italy
facility: Clinica Fabia Mater
state: RM
Study officials:
affiliation: not affiliated
name: Anna Rita Bigioni
role: STUDY_CHAIR
References: