NCT06121531

Brief Summary

This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 30, 2023

Last Update Submit

November 7, 2023

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of corrected visual acuity

    The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.

    3 Months

Secondary Outcomes (8)

  • Effectiveness of corrected visual acuity

    1 week, 1 month and 2 months

  • Average contact lens corrected visual acuity

    1 week, 1 month, 2 months and 3 months

  • Change in diopter (Spherical and cylindrical power of subjective optometry)

    1 week, 1 month, 2 months and 3 months

  • Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)

    1 week, 1 month, 2 months and 3 months

  • Lens broken rate

    1 week, 1 month, 2 months and 3 months

  • +3 more secondary outcomes

Study Arms (2)

Group I

ACTIVE COMPARATOR

Si-Hy (Samfilcon A)

Device: Soft Contact Lens

Group II

EXPERIMENTAL

Si-Hy (Otufilcon A)

Device: Soft Contact Lens

Interventions

Soft Contact LensDEVICE

Vision Correction

Group IGroup II

Eligibility Criteria

Age20 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and above.
  • Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
  • Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
  • With +6.00D \~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
  • Have worn soft contact lens for at least 1 month prior to the study.
  • Willing to comply with the required wearing time and use specified contact lens care product.
  • Agree to comply with all study procedures and signed the informed consent form before enrollment.

You may not qualify if:

  • Anterior chamber infection, inflammation, or abnormality.
  • Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
  • Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
  • History of herpes simplex keratitis.
  • History of refractive surgery, keratoconus, or irregular cornea.
  • A pathologically dry eye syndrome (Schirmer test \< 5 mm).
  • Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
  • Currently pregnant or lactation.
  • Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).
  • Have experienced discomfort when wearing hydrogel contact lens.
  • Subjects who are judged unsuitable for the study by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 8, 2023

Study Start

February 1, 2021

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

TW(2)