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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly.

Study Groups

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Eye wearing contact lens

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

Group Type EXPERIMENTAL

Eye Wearing Contact Lens

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes