Trial · NCT04980144
Diquafosol Ophthalmic Solution for Dry Eye Symptoms
NCT04980144, Not applicable, Unknown, He Eye Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Diquafosol Ophthalmic Solution for Dry Eye Symptoms. Trials, record NCT04980144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04980144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diquafosol Ophthalmic Solution for Dry Eye Symptoms
- NCT number
- NCT04980144
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 101 participants, estimated
- Lead sponsor
- He Eye Hospital
- Conditions
- Diabetic Eye Problems
- Interventions
- 3% Diquafosol tetrasodium, 0.1% hyaluronate
- First posted
- 2021-07-28
- Last updated
- 2023-01-12
Source ClinicalTrials.gov
Registered outcomes7
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, 8-weeks | Changes in 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. * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Primary | Tear Film Lipid Layer | Day-0 (baseline), 4-weeks, 8-weeks | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Primary | OSDI Score | Day-0 (baseline), 4-weeks, 8-weeks | Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Secondary | Conjunctival hyperemia (RS score) | Day-0 (baseline), 4-weeks, 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. * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Secondary | Quality of meibum grade | Day-0 (baseline), 4-weeks, 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). * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Secondary | Expressibility of meibum grade | Day-0 (baseline), 4-weeks, 8-weeks | Meibum expressibility will be assessed under a slit-lamp: Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands. * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
| Secondary | Conjunctivocorneal epithelial staining grade | Day-0 (baseline), 4-weeks, 8-weeks | Conjunctivocorneal epithelial staining will be assessed under a slit-lamp: Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe). * Changes at 4-weeks and 8-weeks will be compare with baseline measurements. * Comparison between groups at baseline, 4-weeks and 8-weeks will also be examined |
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.
Papers26
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/NCT04980144
GET https://conductscience.org/api/trials/v1/NCT04980144/papers?page=2