Trial · NCT06537349
Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
NCT06537349, Not applicable, Unknown, He Eye Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye. Trials, record NCT06537349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06537349
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
- NCT number
- NCT06537349
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 30 participants, estimated
- Lead sponsor
- He Eye Hospital
- Conditions
- Dry Eye
- Interventions
- 3% Diquafosol tetrasodium
- First posted
- 2024-08-05
- Last updated
- 2024-08-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pediatric Refractive Error Profile(PREP) questionnaire score | Day-0 (baseline), 2-weeks, 4-weeks | Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed. |
| Secondary | Non-invasive tear break-up time | Day-0 (baseline), 2-weeks, 4-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. |
| Secondary | Tear Film Lipid Layer | Day-0 (baseline), 2-weeks, 4-weeks | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). |
| Secondary | Conjunctivocorneal staining grade | Day-0 (baseline), 2-weeks, 4-weeks | Using fluorescein sodium solution or fluorescein sodium test paper to contact the lower eyelid margin, corneal and conjunctival epithelial defects under the cobalt blue light of the slit lamp microscope showed different morphology, such as green spots, erosion, lamellar defects, ulcers and so on. The following categories: according to the severity of the symptoms can be mild, slit lamp microscope check no obvious signs of ocular surface damage (corneal fluorescein staining point \< 5); Moderate: the extent of corneal damage under the slit lamp microscope did not exceed 2 quadrants and (or) the number of corneal fluorescein staining spots was \>5 and \<30. Severe: the range of corneal damage was 2 quadrants or more and (or) the corneal fluorescent staining spots were more than 30. The fluorescein staining spots in the cornea fused into thick spots, sheets or with filaments. |
| Secondary | Tear meniscus height | Day-0 (baseline), 2-weeks, 4-weeks | Changes in TMH 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 | Ocular Surface Disease Index(OSDI) questionnaire score | Day-0 (baseline), 2-weeks, 4-weeks | the Chinese language-validated OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms, and any condition associated with DED, will be used. Te patient will answer each question on a scale ranging from 0 to 4, with 0 indicating "none of the time" and 4 indicating "all of the time." If a certain question is deemed irrelevant, it will be marked as "not applicable (N/A)" and excluded from the analysis. The OSDI total score is calculated according to the proprietary formula proposed by the authors of the original OSDI. The scale ranges from 0 to 100, with higher scores representing more severe cases of DED. |
| Secondary | Objective visual quality assessment | Day-0 (baseline), 2-weeks, 4-weeks | Using SCHWIND SIRIUS eyes analyzer objective visual quality assessment, including: total higher-order aberrations, spherical aberration, coma makes, clover, and RMS values etc.. |
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.
Papers14
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/NCT06537349
GET https://conductscience.org/api/trials/v1/NCT06537349/registered