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Evaluation of U40-1Y-UV Soft Hydrophilic Contact Lens Safety and Effectiveness: A Randomized, Double-blind, Parallel Controlled Clinical Trial

Evaluation of U40-1Y-UV Soft Hydrophilic Contact Lens Safety and Effectiveness: A Randomized, Double-blind, Parallel Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001019
Enrollment
Unknown
Registered
2010-09-29
Start date
2010-03-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ametropia

Interventions

A:Visco contact lens
B:Hydron contact lens

Sponsors

The First Affiliated Hospital of Medical School of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 55 years old; 2. Able and willing to provide signed informed consent; 3. Correction of the spherical degree between-1.00D and-10.00D; 4. Besides refractive errors no other abnormalities or diseases; 5. No history of ocular trauma or surgery; 6. No eyelid abnormalities or infection; 7. No abnormal or no more than moderate conjunctival conjunctivitis, keratitis, history; 8. No clinically significant abnormal slit lamp examination; 9. No other active eye disease.

Exclusion criteria

Exclusion criteria: 1. Requires the use of ophthalmic drug treatment; 2. Any systemic disease taboo to wear contact lenses or disease or drug treatment will affect the success of the visual wear contacts; 3. Enrolled in this study before 8 weeks have a history of ocular trauma or surgery; 4. In the past 6 weeks of wearing contact lenses (before the test to be stopped at least 1 week wearing time); 5. Eliminate abnormal tear secretion, tear tract Infection; 6. Eye irritation after contact lens wearers may affect; 7. Keratoconus or other corneal irregularities; 8. Pregnancy or breast-feeding women, or for pregnant women; 9. Participated other trail in a month or who are participating in other clinical trials; 10. Any history, according to the researchers judged likely to interfere with test results or increase the risk of patients; 11. The researchers determine the compliance problem and can not strictly enforce the protocal.

Design outcomes

Primary

MeasureTime frame
correction of refractive error;

Secondary

MeasureTime frame
comfort;safety;

Countries

China

Contacts

Public ContactYangshun Gu
guyangshun_1@hotmail.com+86 571 87236397

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026