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Contact LensCLDEQ-8NCT05416528

Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)

An observational study of Contact Lens and Questionnaire, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
How many people
134 participants
Where
1 siteChina
Study dates
18 Nov 2022to 22 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The subjects are residents of Guangzhou, China.

Who may be able to join

  • Age between 18-60
  • Native Chinese citizens with Chinese as first language
  • Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months;
  • Willing to sign informed consent

Who cannot join

  • Any extended wear of SCLs, including wearing toric or multi-focal SCLs
  • Use SCL for monovision correction
  • Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa)
  • Having ocular or systemic disease that would preclude SCL wearing
  • Best corrected visual acuity of less than 0.8 in either eye
  • History of refractive or other types of corneal surgeries
  • Having eyelid abnormalities or functional ocular disorders that would induce relevant discomfort.
  • 8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers

This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China.

Read the detailed description

The aim of this study is to translate the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) into Chinese and evaluate its validity, and reliability among soft contact lens wearers in China. One hundred and thirty-four Chinese soft contact lens wearers will be included in the study. Subjects are required to complete the Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (C-CLDEQ-8) on paper before eye examinations. A subgroup of 50 participants will be asked to complete C-CLDEQ-8 twice to evaluate the repeatability.

Keywords
the 8-item Contact Lens Dry Eye Questionnaire, CLDEQ-8, Contact Lens Discomfort, Questionnaire, Chinese translation and validation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The reliability of the C-CLDEQ-8

    Subjects are asked to complete C-CLDEQ-8. Internal consistency (reliability) of the C-CLDEQ-8 is evaluated using the Cronbach's Alpha analysis and the corrected index of homogeneity. For Cronbach´s Alpha results: < 0.5 is considered unacceptable; 0.5-0.6 poor; 0.6-0.7 questionable; 0.7-0.8 acceptable; 0.8-0.9 good; and > 0.9 excellent.

    Measured: before the ocular examination

Secondary outcomes (2)

  1. The repeatability of the C-CLDEQ-8

    a subgroup of 50 participants are asked to complete C-CLDEQ-8 twice. Intraclasss correlation coefficient between the two scores of the first and second questionnaire evaluation is used to evaluate the repeatability. >0.7 is considered reliable.

    Measured: before and after the ocular examination on the same day of visit

  2. Cutoff score for C-CLDEQ-8 to predict "Excellent/Very Good" overall of SCLs.

    The Youden-index method is used to determine the cutoff value of the C-CLDEQ-8 score that maximized sensitivity+specificity -1.

    Measured: before the ocular examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start18 Nov 2022
  3. Primary completion18 Nov 2022
  4. Study completion22 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416528
Sponsor's protocol ID
2022KYPJ100
Acronym
CLDEQ-8
Status last verified
Nov 2023
First submitted
8 Jun 2022
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gao J, Lai Z, Hu Y, Yang X. Translation and validation of the 8-item contact lens dry eye questionnaire (CLDEQ-8) among Chinese soft contact lens wearers. Cont Lens Anterior Eye. 2025 Jun;48(3):102366. doi: 10.1016/j.clae.2024.102366. Epub 2025 Jan 10.

    PubMed 39799006

Questions about this trial

What is this clinical trial studying?

An observational study of Contact Lens and Questionnaire, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The reliability of the C-CLDEQ-8 (time frame: before the ocular examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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