BridgeMD
Tests treatment safety and results for Refractive Ametropia
Official title A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
ClinicalTrials.gov ID: NCT07322211
What this study is testing
- What it's testing
- 13 weeks, open-label, daily disposable contact lens dispensing study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult with an age ≥ 18;
- Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours...
- Participant must be stop wearing any contact lenses more than 7 days prior to screening;
- Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
- Astigmatism of 1.25D or less in both eyes;
You likely can't join if
- Women who are currently pregnant;
- Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
- Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study...
- Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
- Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
- Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery...
See the full eligibility criteria
- Adult with an age ≥ 18;
- Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal...
- Participant must be stop wearing any contact lenses more than 7 days prior to screening;
- Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
- Astigmatism of 1.25D or less in both eyes;
- Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
- Participant must be able to be successfully fit with study lenses;
- The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
- The participant must read and sign the Informed Consent Form.
- Women who are currently pregnant;
- Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
- Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as...
- Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
- Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
- Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and/or refractive surgery during the study;
- Current or history of herpetic keratitis in either eye;
- Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
- Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test \< 5 mm/5 min), recurrent corneal erosions, aphakia, or moderate or above corneal...
- Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
- Participation in any treatment clinical trial within 30 days prior to study enrollment;
- Any biomicroscopy findings at screening that are Grade 3 or higher and/or corneal neovascularization that is Grade 2 or higher and/or presence of corneal infiltrates;
- Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;
- Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
- Participants are considered ineligible for the study as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.