Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351410
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-02
Brief Title:
Assessment of Tear Production Corneal Staining and Comfort Level Wearing Different Types of Contact Lenses
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
Assessment of Tear Production Corneal Staining and Comfort Level After One Day of Wearing FDA Group I II III IV and V Contact Lenses Among Pre-Graduate Students at UKM Kuala Lumpur Campus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market The study involves contact lens participants all of whom are students enrolled at UKM Before the study participants were instructed to discontinue wearing their usual contact lenses for two weeks The lenses utilized in this clinical trial all possess current refractive power Participants are required to wear the lenses for an entire day only Upon completion of the study participants will be requested to complete a brief questionnaire
Detailed Description:
Before commencing the trial all participants will undergo an anterior segment examination to ensure the eyes are in a healthy state free from corneal diseases Two parameters will be measured during this examination Tear Break-Up Time TBUT which is a non-invasive method used to assess tear break-up and the Schirmer Test where a strip is placed on the lower eyelid for five minutes to evaluate tear wetting of the strip
The level of comfort after wearing contact lenses for 8 hours will be assessed using the Contact Lens Discomfort Index questionnaire
The sample size is determined using the formula by Daniel 1999 Ten percent of the total sample size represents the number of subjects for this study Considering a dropout rate of 10 this study requires 18 subjects
The level of comfort after wearing contact lenses for 8 hours will be assessed using the Contact Lens Discomfort Index questionnaire
The sample size is determined using the formula by Daniel 1999 Ten percent of the total sample size represents the number of subjects for this study Considering a dropout rate of 10 this study requires 18 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None