Trial · NCT02608489
Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
NCT02608489, Not applicable, Completed, Soonchunhyang University Hospital; results first posted 2016-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery. Trials, record NCT02608489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02608489
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
- NCT number
- NCT02608489
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 86 participants, actual
- Lead sponsor
- Soonchunhyang University Hospital
- Conditions
- Dry Eye Syndromes
- Interventions
- Diquafosol (Diquas), Sodium Hyaluronate (Hyalein)
- First posted
- 2015-11-18
- Last updated
- 2016-10-17
- Results first posted
- 2016-10-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | 12 weeks | The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome. |
| Primary | Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. | 12 weeks | Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured. |
| Primary | Changes in HOAs After Blinking That is Related to Dry Eye Severity. | 12 weeks | Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability. |
| Primary | Tear Break-up Time (TBUT) That is Related to Dry Eye Severity. | 12 weeks | TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film. |
| Primary | Corneal Fluorescein Staining That is Related to Dry Eye Severity. | 12 weeks | Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section). 0 : best score (no corneal damage) 15 : worst score (severe corneal damages) |
| Primary | Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity | 12 weeks | Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section). 0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages) |
| Secondary | Grades of Anterior Chamber Cells. | 12 weeks | Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme. grade 0 : \<1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : \>50 cells in field Field size is a 1 mm X 1 mm slit beam |
| Secondary | Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort | 12 weeks | Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | 12 weeks | scores on a scale | MEAN | |
| PRIMARY | Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. | 12 weeks | mm | MEAN | |
| PRIMARY | Changes in HOAs After Blinking That is Related to Dry Eye Severity. | 12 weeks | microns | MEAN | |
| PRIMARY | Tear Break-up Time (TBUT) That is Related to Dry Eye Severity. | 12 weeks | seconds | MEAN | |
| PRIMARY | Corneal Fluorescein Staining That is Related to Dry Eye Severity. | 12 weeks | scores | MEAN | |
| PRIMARY | Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity | 12 weeks | Scores on a scale | MEAN | |
| SECONDARY | Grades of Anterior Chamber Cells. | 12 weeks | grade | MEAN | |
| SECONDARY | Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort | 12 weeks | Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Diqufosol | Baseline | 21.09 | Standard Deviation 3.86 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Hyaluronate | Baseline | 23.00 | Standard Deviation 2.66 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Diqufosol | Postoperative week 1 | 31.28 | Standard Deviation 5.49 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Hyaluronate | Postoperative week 1 | 20.31 | Standard Deviation 4.63 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Diqufosol | Postoperative week 4 | 20.31 | Standard Deviation 4.63 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Hyaluronate | Postoperative week 4 | 23.00 | Standard Deviation 3.19 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Diqufosol | Postoperative week 12 | 9.76 | Standard Deviation 7.95 | scores on a scale |
| an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. | Hyaluronate | Postoperative week 12 | 16.92 | Standard Deviation 13.11 | scores on a scale |
| Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. | Diqufosol | Baseline | 3.61 | Standard Deviation 0.84 | mm |
| Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. | Hyaluronate | Baseline | 3.69 | Standard Deviation 0.58 | mm |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diqufosol | 43 | |
| Overall Study | STARTED | Hyaluronate | 43 | |
| Overall Study | COMPLETED | Diqufosol | 30 | |
| Overall Study | COMPLETED | Hyaluronate | 33 | |
| Overall Study | NOT COMPLETED | Diqufosol | 13 | |
| Overall Study | NOT COMPLETED | Hyaluronate | 10 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Severe irritation | Eye disorders | Diqufosol | 1 | 31 | 1 |
| other | Severe irritation | Eye disorders | Hyaluronate | 0 | 33 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diqufosol | ||
| Total, all-cause mortality | Hyaluronate | ||
| Total, other adverse events | Diqufosol | 1 | 31 |
| Total, other adverse events | Hyaluronate | 0 | 33 |
| Total, serious adverse events | Diqufosol | 0 | 31 |
| Total, serious adverse events | Hyaluronate | 0 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diqufosol vs Hyaluronate: Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort | Trial comparisons |
| Diqufosol vs Hyaluronate: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02608489
GET https://conductscience.org/api/trials/v1/NCT02608489/results?page=2