NCT05962528

Brief Summary

To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 16, 2023

Last Update Submit

July 26, 2023

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Subjective questionnaire

    The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms

    1 day (Once time after wearing the soft lens)

Study Arms (5)

Type 1 group

EXPERIMENTAL

Toric soft lens with high sagittal height

Device: Soft lens

Type 2 group

EXPERIMENTAL

Toric soft lens with low sagittal height

Device: Soft lens

Type 3 group

EXPERIMENTAL

Spherical soft lens with high sagittal height

Device: Soft lens

Type 4 group

EXPERIMENTAL

Spherical soft lens with low sagittal height

Device: Soft lens

Control group

PLACEBO COMPARATOR

Traditional spherical soft lens

Device: Soft lens

Interventions

Soft lensDEVICE

Patients were randomly fitted with five different designs of soft lenses

Control groupType 1 groupType 2 groupType 3 groupType 4 group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age more than 18 years
  • No active eye disease
  • soft lenses for the experiment can be successfully worn and all examinations can be completed as required

You may not qualify if:

  • Active eye disease
  • BCVA less than 20/25
  • Those who are too small or tight eyelids are not suitable for wearing soft lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

Central Study Contacts

Tiejing Sun, MD

CONTACT

+8627306525suntiejing0109@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2023

First Posted

July 27, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

December 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)