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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351410
• Other study ID #: JEP 2023-679
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: National University of Malaysia
• Contact: Mohd Norhafizun Mohd Saman, MSc
• Phone: 0122431452
• Email: hafizunsaman[@]ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: February 28, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 29 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Malaysia	Optometry Clinic	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

Arroyo-Del Arroyo C, Fernandez I, Lopez-de la Rosa A, Pinto-Fraga J, Gonzalez-Garcia MJ, Lopez-Miguel A. Design of a questionnaire for detecting contact lens discomfort: the Contact Lens Discomfort Index. Clin Exp Optom. 2022 Apr;105(3):268-274. doi: 10.1 — View Citation

Asharlous A, Jafarzadehpur E, Mirzajani A, Khabazkhoob M, Heydarian S, Taghipour A. Tear Deformation Time and optical quality in eyes wearing silicone hydrogel contact lenses. J Curr Ophthalmol. 2016 Jul 25;28(4):226-227. doi: 10.1016/j.joco.2016.07.002. eCollection 2016 Dec. — View Citation

Brautaset RL, Nilsson M, Leach N, Miller WL, Gire A, Quintero S, Bergmanson JP. Corneal and conjunctival epithelial staining in hydrogel contact lens wearers. Eye Contact Lens. 2008 Nov;34(6):312-6. doi: 10.1097/ICL.0b013e3181891439. — View Citation

Outcome

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