UNICON silicone hydrogel daily disposable soft contact lenses — safety and performance

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

This 13-week test will see if UNICON silicone hydrogel daily disposable contact lenses are safe and comfortable for adults who already wear soft contact lenses and fit the prescription range.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Days and up
• Sex: All
• Sponsor: Unicon Optical Co. Ltd. (Industry-sponsored)
• Locations: 2 sites (Kaohsiung City and 1 other locations)
• Trial ID: NCT07322211 on ClinicalTrials.gov

What this trial studies

This is an open-label, 13-week daily-disposable lens dispensing study enrolling adult, experienced soft contact lens wearers. Participants will be fitted with UNICON silicone hydrogel daily disposable lenses within the power range −2.00 D to −6.00 D and astigmatism ≤1.25 D and followed with scheduled visits for visual acuity and ocular health checks. The primary outcome is the number of suspended eyes (total suspended eye(s)) over the study period, with secondary observations on comfort and overall clinical performance. Eligibility requires successful prior soft lens wear and ability to achieve 1.0 decimal (0.0 logMAR) visual acuity in each eye with the study lenses.

Who should consider this trial

Good fit: Adults aged 18 or older who are current soft contact lens wearers with refractive powers between −2.00 D and −6.00 D, astigmatism ≤1.25 D, and correctable to 1.0 decimal (0.0 logMAR) in each eye are ideal candidates.

Not a fit: People with prescriptions outside the allowed power range, astigmatism greater than 1.25 D, pregnant or lactating women, non–contact-lens wearers, or those who cannot be fit with the study lenses are unlikely to benefit.

Why it matters

Potential benefit: If successful, these lenses could provide a safe, comfortable daily disposable option for adults needing correction in the specified prescription range.

How similar studies have performed: Similar silicone hydrogel daily disposable lenses have an established track record of safety and comfort in prior clinical work, so this approach builds on well-known technology.

Eligibility criteria

Inclusion Criteria:

1. Adult with an age ≥ 18;
2. 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 confirmation);
3. Participant must be stop wearing any contact lenses more than 7 days prior to screening;
4. Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;
5. Astigmatism of 1.25D or less in both eyes;
6. Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;
7. Participant must be able to be successfully fit with study lenses;
8. The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;
9. The participant must read and sign the Informed Consent Form.

Exclusion Criteria:

1. Women who are currently pregnant;
2. Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);
3. 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 determined by the investigator;
4. Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;
5. Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;
6. 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;
7. Current or history of herpetic keratitis in either eye;
8. Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;
9. 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 distortion;
10. Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);
11. Participation in any interventional clinical trial within 30 days prior to study enrollment;
12. 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;
13. 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;
14. Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;
15. Participants are considered ineligible for the study as judged by the investigator.

Where this trial is running

Kaohsiung City and 1 other locations

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Nick Liao

Conditions Refractive Ametropia