Clinical trial NCT02637804: Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Official title: Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
Primary purpose: OTHER

Brief summary: Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.

Detailed description: The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.

The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

Study groups:

Group 1: stenfilcon A vs. narafilcon A

Group 2: stenfilcon A vs. delefilcon A

Eligibility criteria: Inclusion Criteria:

- A person is eligible for inclusion in the study if he/she:

* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
* Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
* Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
* Is willing to comply with the wear schedule.
* Is willing to comply with the visit schedule

Exclusion Criteria:

- A person will be excluded from the study if he/she:

* Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
* Has a CL prescription outside the range of the inclusion power range
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 in either eye
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Pain and Foreign Body Sensation
timeFrame: 1 week
measure: Itching Sensation on Removal
timeFrame: 1 week
measure: Red Eye Sensation
timeFrame: 1 week
measure: Dryness
timeFrame: 1 week
measure: Comfort
timeFrame: 1 week
measure: Vision
timeFrame: 1 week
measure: Handling
timeFrame: 1 week
measure: Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
timeFrame: 1 week
measure: Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
timeFrame: 1 week
Secondary outcomes:
measure: Lens Fit - Horizontal Centration
timeFrame: Baseline
measure: Lens Fit - Horizontal Centration
timeFrame: 1 week
measure: Lens Fit - Vertical Centration
timeFrame: Baseline
measure: Lens Fit - Vertical Centration
timeFrame: 1 week
measure: Lens Fit - Post-blink Movement
timeFrame: Baseline
measure: Lens Fit - Post-blink Movement
timeFrame: 1 week
measure: Lens Fit Overall
timeFrame: Baseline
measure: Lens Fit Overall
timeFrame: 1 week
measure: Conjunctival Redness
timeFrame: 1 week
measure: Limbal Redness
timeFrame: 1 week
measure: Corneal Staining
timeFrame: 1 week
measure: Corneal Neovascularization
timeFrame: 1 week
measure: Conjunctival Staining
timeFrame: 1 week
measure: Corneal Oedema
timeFrame: 1 week
measure: Papillary Conjunctivitis
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Director, Kodama Eye Clinic
name: Yuji Kodama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: