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OpenTrials
Completed

NCT Number: NCT06616480

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

This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BenQ Materials Corporation

Taoyuan, 33341, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old, gender is not limited;
  • Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
  • Both eyes were normal with no other abnormality or disease other than refractive error;
  • Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
  • Astigmatism ≤ 2.0D;
  • T5ar film break-up time (BUT) >5s in both eyes
  • 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;
  • 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

  • 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;
  • Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
  • People who are allergic to contact lens, and people with systemic allergic diseases;
  • Patients with conical corneas or other irregular corneas;
  • 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;
  • Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
  • Those who were eligible for enrollment in only one eye;
  • 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
  • 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;
  • Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.

Treatment and study plan

BenQ Materials DSFNC1 soft hydrophilic contact lenses

Device

Test lenses were to be worn for approximately 90 days.

Visco SiHy Color soft hydrophilic contact lenses

Device

Control lenses were to be worn for approximately 90 days

Primary outcomes

  1. Efficacy evaluation indexes

    Time frame: after wearing lenses for 7 days

    The proportion of contact lens-corrected eyesight, The percentage of changes in iris color

Secondary outcomes

  1. Time of Break up time (BUT)

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    Comparison of BUT time results between the experimental group and control group

  2. Distance Uncorrected visual acuity (UCVA)

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    Comparison of distance uncorrected visual acuity results between the experimental group and control group

  3. Fitness of the contact

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    the position of lens on the ocular surface, the coverage, tightness and movability of len

Other outcomes

  1. Efficacy evaluation indexes

    Time frame: on the day of wearing the lens and after wearing lenses for 30 days and 90 days

    The percentage of iris color change after wearing lenses ,The proportion of contact lens corrected eyesight

Sponsors and collaborators

Lead sponsor

BenQ Materials Corporation

Industry

Registry information

Official study title

Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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