Dry EyeNCT06351410
Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses
A study testing Eye Wearing Contact Lens in people with Dry Eye and Dry Eye Syndromes, run by National University of Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 19 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Contact Lens-induced Corneal Fluorescein Staining
- What is being tested?
- Eye Wearing Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 May 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Eye Wearing Contact Lens
- Keywords
- Dry Eye, Contact Lens, Corneal Staining, Tears, Comfort
- Medical subject headings
- Dry Eye Syndromes, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Wearing Contact LensDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Eye Wearing Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
To asess the quality of tears in eyes wearing contact lenses
NIBUT is done on patients pre and post wear. (10 seconds)
Measured: 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
Measured: 5 minutes
To assess comfort level of participants using CL Discomfort Index Questionaire
8 questions to be answered for each lens
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start2 May 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haliza Abdul Mutalib, PhD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351410
- Sponsor's protocol ID
- JEP 2023-679
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27830209Brautaset 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.
PubMed 18997539Arroyo-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.
PubMed 33735595
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06351410
- Acronym / sponsor ID
- JEP 2023-679
- Keywords
- Dry Eye, Contact Lens, Corneal Staining, Tears, Comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Eye wearing contact lens | Experimental | Device: Eye Wearing Contact LensThe 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 |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Wearing Contact LensEach 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 | Device | Eye wearing contact lens |
Primary outcome
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
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)
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
To assess comfort level of participants using CL Discomfort Index Questionaire
Time frame: 10 minutes
8 questions to be answered for each lens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 27830209Asharlous 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.
- Background: PubMed 18997539Brautaset 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.
- Results publication: PubMed 33735595Arroyo-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haliza Abdul Mutalib, PhD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Wearing Contact Lens in people with Dry Eye and Dry Eye Syndromes, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohd Norhafizun Mohd Saman, MSc (0122431452, hafizunsaman@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the quantity of tears in eyes wearing contact lenses (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06351410, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.