Clinical trial NCT06351410: Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Contact Lens-induced Corneal Fluorescein Staining
Keywords: Dry Eye
Contact Lens
Corneal Staining
Tears
Comfort
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To assess the quantity of tears in eyes wearing contact lenses
timeFrame: 5 minutes
measure: To asess the quality of tears in eyes wearing contact lenses
timeFrame: 5 minutes
measure: To assess corneal staining in eyes wearing contact lenses
timeFrame: 5 minutes
measure: To assess comfort level of participants using CL Discomfort Index Questionaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Optometry Clinic
Study officials:
affiliation: National University of Malaysia
name: Haliza Abdul Mutalib, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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: 10.1080/08164622.2021.1896945. Epub 2021 Mar 18.