Clinical trial NCT02341859: Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Official title: Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Detailed description: The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft spherical contact lens wearer
* Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
* Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) 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
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Is not a habitual wearer of soft spherical contact lenses
* Has a contact lens prescription outside the range of the available parameters of the study lenses
* Has a contact lens 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 contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade \> 2) 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 such as:

  * Moderate to severe dry eye
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study

Primary outcomes:
measure: Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
Secondary outcomes:
measure: Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline
measure: Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline, 3 hours, 6 hours
measure: Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline, 3 hours, 6 hours
measure: Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline and 6 hours
measure: Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: Baseline, 3 hours, 6 hours
measure: Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
measure: Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
timeFrame: 6 hours
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
Study officials:
affiliation: CRC-UC Berkeley
name: Meng C Lin, OD PhD
role: PRINCIPAL_INVESTIGATOR
References: