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

NCT06351410 | Not Yet Recruiting DMC

• 1 other identifier: JEP 2023-679
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dry Eye; Contact Lens; Corneal Staining; Tears; Comfort

Outcome Measures

Primary Outcomes (4)

• 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

• To asess the quality of tears in eyes wearing contact lenses

  NIBUT is done on patients pre and post wear. (10 seconds)

  5 minutes

• 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

• To assess comfort level of participants using CL Discomfort Index Questionaire

  8 questions to be answered for each lens

  10 minutes

Study Arms (1)

Eye wearing contact lens

EXPERIMENTAL

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

Interventions

Eye Wearing Contact Lens 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

Eye wearing contact lens

Eligibility Criteria

• Age: 19 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Optometry Clinic

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 27830209 BACKGROUND

• 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.

  PMID: 18997539 BACKGROUND

• 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.

  PMID: 33735595 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes; Lacerations

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• Haliza Abdul Mutalib, PhD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Norhafizun Mohd Saman, MSc

CONTACT

0122431452; hafizunsaman@ukm.edu.my

Bashirah Ishak, PhD

CONTACT

0133889963; bashirah@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 2, 2024
• Primary Completion: July 30, 2024
• Study Completion: February 28, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

MY (1)