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OpenTrials
Completed

NCT Number: NCT07064187

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

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

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Key information

Conditions

Ocular Discomfort

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ba Ria - Vung Tau Eye Hospital

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cationorm single-dose eye drop

Drug

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

Other names: Cationic emulsion

Artificial tear eye drop

Drug

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

Primary outcomes

  1. Frequency and Severity of Blurred Vision symptom

    Time frame: From enrollment to 7 days after surgery

    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

  2. Frequency and Severity of Eye Pain symptom

    Time frame: From enrollment to 7 days after surgery

    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

  3. Frequency and Severity of Watery Eyes symptom

    Time frame: From enrollment to 7 days after surgery

    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

  4. Frequency and Severity of Itchiness symptom

    Time frame: From enrollment to 7 days after surgery

    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

  5. Frequency and Severity of Grittiness symptom

    Time frame: From enrollment to 7 days after surgery

    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

  6. Frequency and Severity of Sensitivity to Light symptom

    Time frame: From enrollment to 7 days after surgery

    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

Secondary outcomes

  1. Frequency and Severity of Discomfort when Reading

    Time frame: From enrollment to 7 days after surgery

    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

  2. Frequency and Severity of Discomfort when Watching TV

    Time frame: From enrollment to 7 days after surgery

    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

  3. Frequency and Severity of Discomfort when Using Computer

    Time frame: From enrollment to 7 days after surgery

    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

  4. Frequency and Severity of Discomfort when Driving at Night

    Time frame: From enrollment to 7 days after surgery

    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

  5. Frequency and Severity of Discomfort when Being Outdoors

    Time frame: From enrollment to 7 days after surgery

    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

  6. Frequency and Severity of Discomfort when Being in Air-Conditioned Areas

    Time frame: From enrollment to 7 days after surgery

    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

Sponsors and collaborators

Lead sponsor

Nguyen Viet Giap

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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