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

NCT07064187 | Completed Phase 4

• 1 other identifier: 30/BVM-KHTH No.2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ocular Discomfort

Keywords

cationorm; artificial tear; pterygium surgery

Outcome Measures

Primary Outcomes (6)

• Frequency and Severity of Blurred Vision symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

• Frequency and Severity of Eye Pain symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

• Frequency and Severity of Watery Eyes symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

• Frequency and Severity of Itchiness symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

• Frequency and Severity of Grittiness symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

• Frequency and Severity of Sensitivity to Light symptom

  All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe

  From enrollment to 7 days after surgery

Secondary Outcomes (6)

• Frequency and Severity of Discomfort when Reading

  From enrollment to 7 days after surgery

• Frequency and Severity of Discomfort when Watching TV

  From enrollment to 7 days after surgery

• Frequency and Severity of Discomfort when Using Computer

  From enrollment to 7 days after surgery

• Frequency and Severity of Discomfort when Driving at Night

  From enrollment to 7 days after surgery

• Frequency and Severity of Discomfort when Being Outdoors

  From enrollment to 7 days after surgery

Study Arms (2)

Cationorm arm

EXPERIMENTAL

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

Drug: Cationorm single-dose eye drop

Artificial tear arm

ACTIVE COMPARATOR

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

Drug: Artificial tear eye drop

Interventions

Cationorm single-dose eye drop DRUG

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

Also known as: Cationic emulsion

Cationorm arm

Artificial tear eye drop DRUG

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

Artificial tear arm

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Having comorbidities that affects the corneal surface symptoms and signs
• Having limitation in behavior and awareness

Sponsors & Collaborators

• Nguyen Viet Giap: lead

Study Sites (1)

Ba Ria - Vung Tau Eye Hospital

Bà Ria, Ba Ria - Vung Tau, 790000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 10815152 BACKGROUND

MeSH Terms

Interventions

Cationorm; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hospital

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: June 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)