Trial · NCT05193331
Use of 3% Diquafosol Topical Ophthalmic Solution for Diabetic Dry Eye
NCT05193331, Not applicable, Unknown, He Eye Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of 3% Diquafosol Topical Ophthalmic Solution for Diabetic Dry Eye. Trials, record NCT05193331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05193331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of 3% Diquafosol Topical Ophthalmic Solution for Diabetic Dry Eye
- NCT number
- NCT05193331
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 70 participants, estimated
- Lead sponsor
- He Eye Hospital
- Conditions
- Diabetic Eye Problems
- Interventions
- 3% Diquafosol tetrasodium
- First posted
- 2022-01-14
- Last updated
- 2022-12-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-invasive tear break-up time | Day-0 (baseline), 4-weeks and 8-weeks | Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. |
| Secondary | Fluorescein and lissamine conjunctival and cornea staining | Day-0 (baseline), 4-weeks and 8-weeks | Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface (Uchino et al., 2012). |
| Secondary | Tear Film Lipid Layer Score | Day-0 (baseline), 4-weeks and 8-weeks | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). \- Tear Film Lipid Layer will be scored as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed. |
| Secondary | Corneal Sensitivity Score | Day-0 (baseline), 4-weeks and 8-weeks | Corneal Sensitivity Score measured with Cochet-Bonnet esthesiometer (in mm filament length) two times (the measurements will be done immediately before starting the medication, including 3 measurements each time. |
| Secondary | MMP-9 detection | Day-0 (baseline), 4-weeks and 8-weeks | InflammaDry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology. Two antigen-specific antibodies capture MMP-9 antigens in the sample, and this complex is captured in a proprietary mode at the test result line, giving rise to a visually observable signal. |
| Secondary | Tear meniscus height | Day-0 (baseline), 4-weeks and 8-weeks | Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded. of the three values was calculated. |
| Secondary | Conjunctival hyperemia (RS score) | Day-0 (baseline), 4-weeks and 8-weeks | Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156\*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0. |
| Secondary | Meibomian gland function and secretion quality | Day-0 (baseline), 4-weeks and 8-weeks | Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum). |
| Secondary | Corneal nerves and immune/inflammatory cells change | Day-0 (baseline), 4-weeks and 8-weeks | HRT III RCM, (Heidelberg Engineering GmbH, Dossenheim, Germany) will be used to record corneal nerves and immune/inflammatory cells change. A total of 5-8 sequence/volume scans were taken from the center of each cornea, focusing on all corneal layers: superficial, intermediate, and basal epithelial layers, sub-basal nerve plexus, anterior, central and posterior stroma, and endothelium. Special attention was given to the basal epithelial layer and sub-basal nerve plexus area to evaluate the nerve plexi and epithelial DC density. Three representative images of the sub-basal nerve plexus and epithelial DCs were selected for analysis for each eye, considering criteria such as whole image in the same layer, best focus and good contrast. |
| Secondary | Dry eye Questionnaire Score | Day-0 (baseline), 4-weeks and 8-weeks | Chinese translated version of the questionnaire will be used to assess the subjective dry eye symptoms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers27
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05193331
GET https://conductscience.org/api/trials/v1/NCT05193331/papers?page=2