Skip to content

Randomized, open, parallel controlled, multicenter, non-inferior clinical trial to evaluate the efficacy and safety of soft hydrophilic contact lenses for correcting refractive errors

Randomized, open, parallel controlled, multicenter, non-inferior clinical trial to evaluate the efficacy and safety of soft hydrophilic contact lenses for correcting refractive errors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074968
Enrollment
Unknown
Registered
2023-08-22
Start date
2022-02-22
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Myopia

Interventions

Experimental group:Soft hydrophilic contact lens1
control group:Soft hydrophilic contact lens2

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) The subject is over 18 years old (including 18 years old), male or female; (2) The subjects voluntarily sign the informed consent, and provide information on the content, process and possible adverse events of the test Be fully aware of; (3) The degree of myopia in both eyes of the subject is within -1.00D ~ -12.00D (including -1.00D and -12.00D SAN),The luminosity is below -0.75D with a -0.75D sphere-column ratio of 3:1; (4) The best corrected visual acuity of all subjects with binocular frames could reach 5.0

Exclusion criteria

Exclusion criteria: (1) Subjects are using topical ophthalmic or systemic medications that may interfere with contact lens fitting (2) The subject has suffered from eye diseases within 3 months, including but not limited to ? Any active acute inflammation of the eye; ? Chronic ocular inflammation such as: chronic keratitis, chronic uveitis, chronic dacryocystitis, chronic eyelid Borderitis, greater than grade 2 giant papillary conjunctivitis, iritis, seborrheic conjunctivitis, etc. ? Other eye disorders: glaucoma, abnormal corneal sensation, dysraphism of the eyelid, ptosis, and hyperopia Strabismus, cataract, keratoconus, etc. ? Ciliary hyperemia 2 grades; ? Bulbar conjunctival congestion = 2 grade; ? Maximum reaction position of palpebral conjunctiva 2 grade; ? Corneal edema (epithelial or stromal edema) = grade 1; ? Corneal epithelial microcapsule Grade 1 ? Corneal endothelial cell density 21 mmHg or <10 mmHg in either eye, or IOP difference of 5 mmHg (5) Slit-lamp examination showed the following results ? Moderate to severe dry eye (presence of multiple quadrants of corneal damage or corneal fluorin by slit-lamp microscopy) Staining spots = 5 or Tear film Break-up Time [TBUT]<2s ? Pterygium;? Scar in the corneal visual axis; (6) subjects were allergic to contact lens materials or related care products; (7) Serious complications occurred during contact lens wearing (8) Subjects had previous corneal surgery or intraocular surgery (9) subjects who wore orthokeratology lenses within 30 days (10) those who participated in drug clinical trials within 3 months or other medical device clinical trials within 1 month Subjects (11) pregnant, lactating or planning to become pregnant in the near future (12) The subject's living or working environment is not suitable for wearing soft contact lenses, such as diffuse dust and drugs in the air Products, aerosols (such as hair spray, volatile chemicals), dust, etc (13) other conditions judged by the investigator as not suitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
corrected visual acuity;

Secondary

MeasureTime frame
corrected visual acuity;

Countries

China

Contacts

Public ContactJun Jiang

Eye Hospital, Wenzhou Medical University

jjhsj@hotmail.com+86 135 0651 1080

Outcome results

None listed

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