NCT06351410

Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 19 Years – 29 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye
• Dry Eye Syndromes
• Contact Lens-induced Corneal Fluorescein Staining

Interventions

Type	Name	Description
DEVICE	Eye Wearing Contact Lens	Each participant will be given 2 types of a different group of contact lenses for each eye and need to wear for 8 hours only. Measurements will be done pre and post wearing of lenses

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-07-30
• Completion: 2025-02-28
• First posted: 2024-04-08
• Last updated: 2024-04-19

Locations

1 site across 1 country: Malaysia