Evaluate The Improvement In Symptoms Of Patients Using Cationorm After Pterygium Surgery

NCT ID: NCT07064187

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2022-08-15

Brief Summary

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The goal of this interventional clinical trial is to learn whether Cationorm can improve symptoms after pterygium surgery. The main question it aims to answer is what is the level of improvement of symptoms after pterygium surgery.

Researchers will compare with other artificial tears (hyaluronic acid, polymers or cellulose derivatives eye drops) arm to see if Cationorm is similar or superior in terms of improvement of symptoms after pterygium surgery.

Participants will

* Take 1 drop Cationorm/artificial tear before and after surgery and during follow up.
* Visit for checkups after 7 days

Detailed Description

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Participants will take:

* Before surgery: 1 drop Cationorm/artificial tear at the eye that will undergo surgery
* After surgery: 1 drop Cationorm/artificial tear at the eye that underwent surgery before eye bandages
* Follow up after surgery: 1 drop Cationorm/artificial tear 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
* Maintenance phase: 7-14 days with the same regimen
* After day 5, if fluorescein staining (-), can add corticosteroid monotherapy or addition with antibiotics
* After 5 days of surgery, can add more antibiotics depend on the symptoms of patients

Conditions

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Ocular Discomfort

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cationorm arm

Participants will take:

* Before surgery: 1 drop Cationorm at the eye that will undergo surgery
* After surgery: 1 drop Cationorm at the eye that underwent surgery before eye bandages
* Follow up after surgery: 1 drop Cationorm 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
* Maintenance phase: 7-14 days with the same regimen

Group Type EXPERIMENTAL

Cationorm single-dose eye drop

Intervention Type DRUG

Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion.

Artificial tear arm

Participants will take:

* Before surgery: 1 drop artificial tear at the eye that will undergo surgery
* After surgery: 1 drop artificial tear at the eye that underwent surgery before eye bandages
* Follow up after surgery: 1 drop artificial tear 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
* Maintenance phase: 7-14 days with the same regimen

Group Type ACTIVE_COMPARATOR

Artificial tear eye drop

Intervention Type DRUG

Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops

Interventions

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Cationorm single-dose eye drop

Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion.

Intervention Type DRUG

Artificial tear eye drop

Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops

Intervention Type DRUG

Other Intervention Names

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Cationic emulsion

Eligibility Criteria

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Inclusion Criteria

* Aged 35-70 years
* Having diagnosis of pterygium grade II or III and planning for pterygium surgery
* Giving consent to participate the study

Exclusion Criteria

* Having comorbidities that affects the corneal surface symptoms and signs
* Having limitation in behavior and awareness
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nguyen Viet Giap

OTHER

Sponsor Role lead

Responsible Party

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Nguyen Viet Giap

Director of Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ba Ria - Vung Tau Eye Hospital

Bà Ria, Ba Ria - Vung Tau, Vietnam

Site Status

Countries

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Vietnam

References

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Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

Reference Type BACKGROUND
PMID: 10815152 (View on PubMed)

Other Identifiers

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30/BVM-KHTH No.2

Identifier Type: -

Identifier Source: org_study_id

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