Skip to content

A prospective, multicenter, randomized, open label, parallel positive controlled clinical study evaluating the effectiveness and safety of hydrogen peroxide contact lens care solution for contact lens wearers

A prospective, multicenter, randomized, open label, parallel positive controlled clinical study evaluating the effectiveness and safety of hydrogen peroxide contact lens care solution for contact lens wearers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088686
Enrollment
Unknown
Registered
2024-08-23
Start date
2024-08-09
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

None

Interventions

Experimental group:Hydrogen peroxide contact lens care solution
Control group:Hydrogen peroxide care solution

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age greater than or equal to 8 years old; 2) The degree of binocular spherical lens is within -4.00D (including -4.00D), the degree of cylindrical lens is within 1.50D, and the best corrected visual acuity for subjective refraction is = 5.0; 3) Capable and willing to comply with all treatments and follow ups; 4) Be able to understand the purpose of the experiment, voluntarily participate, and have the subjects themselves or their legal guardians sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Single eye meets the selection criteria; 2) Having systemic diseases that may affect the eyes, such as diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, a history of sinusitis within 2 years, or other diseases that researchers believe cannot wear contact lenses; 3) Suffering from certain eye diseases that affect the wearing of contact lenses, such as acute or chronic eye diseases, spring catarrhal conjunctivitis, glaucoma, dry eye syndrome (BUT<5s), corneal abnormalities, etc; 4) Patients with a history of allergies to contact lenses or contact lens care products; 5) Patients who are currently using or need to use medications that may cause dry eye or affect vision and corneal curvature, such as immunosuppressants, glucocorticoids, intraocular pressure lowering drugs, and low concentrations of atropine; 6) Individuals with a history of intraocular surgery; 7) Patients with abnormal intraocular pressure (normal range of intraocular pressure is 10-21mmHg, and the difference in intraocular pressure between the eyes should be = 5mmHg); 8) Individuals who have participated in clinical trials of other drugs within 90 days prior to screening, and those who have participated in clinical trials of other medical devices within 30 days prior to screening; 9) Patients who have worn orthokeratology lenses within the past 30 days; 10) Those who are pregnant, breastfeeding, or planning to become pregnant at the time of enrollment; 11) Those who cannot follow up according to medical advice; 12) The examination results indicate that patients have contraindications or are not suitable for wearing contact lenses; 13) Researchers determine other situations where patients are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
BCVA (Best Corrected Visual Acuity) with contact lens;Sediment on the front surface of the lens;Sediment on the back surface of the lens;

Countries

China

Contacts

Public ContactLihua Li

Tianjin Eye Hospital

tysgzxlccs@163.com+86 137 5200 7098

Outcome results

None listed

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