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

National University of Malaysia

Status: Not yet enrolling

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

Treatments: Device: Eye Wearing Contact Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT06351410

JEP 2023-679

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 19 to 29 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Eye wearing contact lens

Experimental group

Description:

The participant will be given two contact lenses (Lens A and B) to be placed on each eye. This phase will be repeated with C \&D and lens E \& F at different times. Each phase will have a 2 weeks wash-off period

Treatment:

Device: Eye Wearing Contact Lens