Search / Trial NCT06616480

A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses

Launched by BENQ MATERIALS CORPORATION · Sep 25, 2024

Trial Information

Current as of October 08, 2024

Completed

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥ 18 years old, gender is not limited;
  • 2. Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
  • 3. Both eyes were normal with no other abnormality or disease other than refractive error;
  • 4. Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
  • 5. Astigmatism ≤ 2.0D;
  • 6. T5ar film break-up time (BUT) \>5s in both eyes
  • 7. Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol;
  • 8. Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.
  • Exclusion Criteria:
  • 1. Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;
  • 2. Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
  • 3. People who are allergic to contact lens, and people with systemic allergic diseases;
  • 4. Patients with conical corneas or other irregular corneas;
  • 5. Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;
  • 6. Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
  • 7. Those who were eligible for enrollment in only one eye;
  • 8. Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial
  • 9. Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial;
  • 10. Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.

About Benq Materials Corporation

BenQ Materials Corporation is a leading technology firm specializing in advanced materials and innovative solutions for various industries, including electronics, healthcare, and renewable energy. With a strong commitment to research and development, BenQ Materials is dedicated to enhancing product performance and sustainability through cutting-edge technologies. The company actively engages in clinical trials to evaluate and validate the efficacy of its novel materials and applications in medical settings, aiming to contribute to improved patient outcomes and the advancement of healthcare solutions. With a focus on quality, safety, and regulatory compliance, BenQ Materials Corporation strives to leverage its expertise to drive innovation in the clinical research landscape.

Locations

Taoyuan, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0