Clinical trial NCT06121531: A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
Official title: A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Yung Sheng Optical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 20 years old and above.
2. Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
4. With +6.00D \~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
5. Have worn soft contact lens for at least 1 month prior to the study.
6. Willing to comply with the required wearing time and use specified contact lens care product.
7. Agree to comply with all study procedures and signed the informed consent form before enrollment.

Exclusion Criteria:

1. Anterior chamber infection, inflammation, or abnormality.
2. 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.
3. 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).
4. History of herpes simplex keratitis.
5. History of refractive surgery, keratoconus, or irregular cornea.
6. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5 from page 38 to 43).
7. A pathologically dry eye syndrome (Schirmer test \< 5 mm).
8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
9. Currently pregnant or lactation.
10. Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).
11. Have experienced discomfort when wearing hydrogel contact lens.
12. Subjects who are judged unsuitable for the study by the investigators.

Primary outcomes:
measure: The effectiveness of corrected visual acuity
timeFrame: 3 Months
Secondary outcomes:
measure: Effectiveness of corrected visual acuity
timeFrame: 1 week, 1 month and 2 months
measure: Average contact lens corrected visual acuity
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Change in diopter (Spherical and cylindrical power of subjective optometry)
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Lens broken rate
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Lens fitting (lens centration, lens movement, coverage, and tightness)
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Subjective acceptance (comfort, vision, lens handling, lens cleaning)
timeFrame: 1 week, 1 month, 2 months and 3 months
measure: Lens state (lens front surface wettability, front surface deposits, back surface deposits)
timeFrame: 1 week, 1 month, 2 months and 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References: