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Randomized, double-blind, parallel-controlled trial to evaluate the effectiveness and safety of 'VDM' contact lens

Randomized, double-blind, parallel-controlled trial to evaluate the effectiveness and safety of 'VDM' contact lens

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013989
Enrollment
Unknown
Registered
2017-12-16
Start date
2011-06-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

refractive error

Interventions

experiment group:VDM contact lens
Control group:Optima Easy contact lens

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. signed informed consent, aged 14-45 years of myopia, male and female; 2. the eyes need to correct the contact lens degrees between -1.0D to -9.0D; 3. eyes need to correct astigmatism less than or equal to 1.0D; 4. no other diseases and abnormalities; 5. able and willing to comply with all the treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. within a month have been involved in other drug or medical device clinical trials; 2. any abnormal eye or infection; 3. in the case of wearing test lenses need to use any ophthalmic drugs; 4. selected the first 8 weeks before the experiment ocular trauma or surgery history; 5. in the past 4 weeks to wear hard contact lenses; 6. keratoconus or other irregular corneal morphology; 7. tear secretion or discharge abnormalities; 8. any serious systemic / ocular disease or pathological condition; 9. for some reason, do not comply with the instructions and guidance in the agreement; 10. women who were pregnant, breast-feeding or pregnant at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
refraction;ocular examination;lens fit state;lens;

Countries

China

Contacts

Public ContactQu Xiaomei

Eye and ENT hospital, Fudan University

quxiaomei2002@126.com+86 021-64377134

Outcome results

None listed

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