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

April 17, 2024 updated by: National University of Malaysia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50300
        • Optometry Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Haliza Abdul Mutalib, PhD, National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP 2023-679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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