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

Not Applicable

Not yet recruiting

• Conditions: Dry Eye; Contact Lens-induced Corneal Fluorescein Staining; Dry Eye Syndromes

• Registration Number: NCT06351410
• Lead Sponsor: National University of Malaysia

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-08
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-02
• Primary Completion: 2024-07-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy Volunteers
• Age 19-29 years old
• Refractive error is less than -6.00DS with astigmatism is less than -1.00DC
• Have experience wearing Contact Lenses but agree to stop wearing them for 2 weeks before the study starts

Exclusion Criteria

• smokers (Ward et al. 2010)
• participants with ocular disease or trauma which includes Lasik patients and intra/extraocular surgery.
• pregnant females (Yenerel & Kucumen 2015).
• participants taking medication for systemic diseases (Fraunfelder et al. 2012).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the quantity of tears in eyes wearing contact lenses	5 minutes	Schirmer Test is done on patients pre and post-wear. Results will be taken after 5 minutes of measurement using Schirmer Strips
To asess the quality of tears in eyes wearing contact lenses	5 minutes	NIBUT is done on patients pre and post wear. (10 seconds)
To assess comfort level of participants using CL Discomfort Index Questionaire	10 minutes	8 questions to be answered for each lens
To assess corneal staining in eyes wearing contact lenses	5 minutes	Fluorescein in instill at the conjunctiva and staining is observed using cobalt blue light

Trial Locations

Locations (1)

Optometry Clinic; 🇲🇾 Kuala Lumpur, Malaysia