NCT06158906

Brief Summary

This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2024

Completed
Last Updated

February 20, 2024

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 28, 2023

Last Update Submit

February 17, 2024

Conditions

Keywords

qestionnaire

Outcome Measures

Primary Outcomes (1)

  • OSDI12

    The 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 following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome

    Baseline

Study Arms (1)

Study group

Dry eye patients were recruited to fill in the questionnaire

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have been diagnosed with dry eye

You may qualify if:

  • Diagnosed dry eye
  • Able and willing to comply with the schedule
  • Able to read and understand the C-OSDI-12 questionnaire independently

You may not qualify if:

  • The researchers judged to be not suitable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, None Selected, 110034, China

Location

Related Publications (6)

  • Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.

    PMID: 28736343BACKGROUND
  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

    PMID: 28736335BACKGROUND
  • Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

    PMID: 10815152BACKGROUND
  • Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.

    PMID: 12131034BACKGROUND
  • Lu F, Tao A, Hu Y, Tao W, Lu P. Evaluation of Reliability and Validity of Three Common Dry Eye Questionnaires in Chinese. J Ophthalmol. 2018 Aug 27;2018:2401213. doi: 10.1155/2018/2401213. eCollection 2018.

    PMID: 30225139BACKGROUND
  • Midorikawa-Inomata A, Inomata T, Nojiri S, Nakamura M, Iwagami M, Fujimoto K, Okumura Y, Iwata N, Eguchi A, Hasegawa H, Kinouchi H, Murakami A, Kobayashi H. Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease. BMJ Open. 2019 Nov 25;9(11):e033940. doi: 10.1136/bmjopen-2019-033940.

    PMID: 31772113BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

December 1, 2023

Primary Completion

February 17, 2024

Study Completion

February 17, 2024

Last Updated

February 20, 2024

Record last verified: 2023-11

Locations