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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
Participants will take:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cationorm arm | Experimental | Participants will take:
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| Artificial tear arm | Active Comparator | Participants will take:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cationorm single-dose eye drop | Drug | Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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:
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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Discomfort when Reading | 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:
Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ba Ria - Vung Tau Eye Hospital | BÃ Ria | Ba Ria - Vung Tau | 790000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10815152 | Background | 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. |
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| ID | Term |
|---|---|
| C000598600 | Cationorm |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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| Artificial tear eye drop | Drug | Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops |
|
| 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:
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:
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:
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 |
| From enrollment to 7 days after surgery |
| Frequency and Severity of Discomfort when Watching TV | 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:
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 Discomfort when Using Computer | 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:
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 Discomfort when Driving at Night | 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:
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 Discomfort when Being Outdoors | 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:
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 Discomfort when Being in Air-Conditioned Areas | 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:
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 |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |