Tinted Contact LenseNCT02537275
Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function
A study testing EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea and EyeLIKe Shine, Koryo Eyetech Co in people with Tinted Contact Lense, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinted Contact Lense
- What is being tested?
- EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea and EyeLIKe Shine, Koryo Eyetech Co
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jun 2015
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal subject
- aged above 20 years old
Who cannot join
- subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease,
- patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 102-752
About this study
Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.
- Conditions
- Tinted Contact Lense
- Being tested
- EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea, EyeLIKe Shine, Koryo Eyetech Co
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, KoreaDevice
tinted contact lens, daily-wear tinted lens
EyeLIKe Shine, Koryo Eyetech CoDevice
clear lens
| Study group | Role | What they receive |
|---|---|---|
| wearing contact lense group | Experimental | normal subjects after wearing tinted/normal contact lenses Receives: Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea; Device: EyeLIKe Shine, Koryo Eyetech Co |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of best-corrected visual acuity (BCVA)
Measured: 1 day
Secondary outcomes (2)
Total score of ocular higher-order aberrations
ocular higher-order aberrations measured by iTrace (Tracey Technologies, Houston, Texas, USA; software V.4.1.0)
Measured: 1 day
contrast sensitivity with tinted lense
contrast sensitivity measured by Optec 6500 test system (Stereo Optical Co, Chicago, Illinois, USA) at five spatial frequencies (1.5, 3, 6, 12 and 18 cycles/degree (cpd)) under photopic (luminance value of 85 candelas/square metre (cd/m2)) and mesopic conditions (target luminance value of 3 cd/m2) with or without glare after wearing clear lens and tinted lenses with different pigment-free optical zone diameters (4, 5 and 6 mm).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinted Contact LenseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537275
- Sponsor's protocol ID
- 1-2014-0024
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung JW, Kim SM, Han SH, Kim EK, Seo KY, Kim TI. Effect of the pigment-free optical zone diameter of decorative tinted soft contact lenses on visual function. Br J Ophthalmol. 2016 May;100(5):633-7. doi: 10.1136/bjophthalmol-2015-306731. Epub 2015 Sep 16.
PubMed 26377415
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function
- ClinicalTrials.gov ID
- NCT02537275
- Acronym / sponsor ID
- 1-2014-0024
- Conditions
- Tinted Contact Lense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Sep 2015 (estimated)
- 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.
Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wearing contact lense group | Experimental | Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea, Device: EyeLIKe Shine, Koryo Eyetech Conormal subjects after wearing tinted/normal contact lenses |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- normal subject
- aged above 20 years old
Key exclusion criteria (2 listed)
- subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease,
- patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
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 |
|---|---|---|
| EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Koreatinted contact lens, daily-wear tinted lens | Device | wearing contact lense group |
| EyeLIKe Shine, Koryo Eyetech Coclear lens | Device | wearing contact lense group |
Primary outcome
score of best-corrected visual acuity (BCVA)
Time frame: 1 day
2 secondary outcomes
Total score of ocular higher-order aberrations
Time frame: 1 day
contrast sensitivity with tinted lense
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Derived from this study: PubMed 26377415Jung JW, Kim SM, Han SH, Kim EK, Seo KY, Kim TI. Effect of the pigment-free optical zone diameter of decorative tinted soft contact lenses on visual function. Br J Ophthalmol. 2016 May;100(5):633-7. doi: 10.1136/bjophthalmol-2015-306731. Epub 2015 Sep 16.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea and EyeLIKe Shine, Koryo Eyetech Co in people with Tinted Contact Lense, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Sep 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of best-corrected visual acuity (BCVA) (time frame: 1 day). 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 NCT02537275, which also lists 1 linked publication.
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 1 Sep 2015.