Clinical trial NCT02727816: Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Official title: Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Detailed description: This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Eligibility criteria: Inclusion Criteria:

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

* 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 CL (Contact Lens) wearer.
* Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
* 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:

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

* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to - 6.00D
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) 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 such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GPC) 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: Centration - Pair One
timeFrame: Baseline and 1 hour
measure: Centration - Pair Two
timeFrame: Baseline and 1 hour
measure: Centration - Pair Three
timeFrame: Baseline and 1 hour
measure: Centration - Pair Four
timeFrame: Baseline and 1 hour
measure: Post-blink Movement - Pair One
timeFrame: Baseline
measure: Post-blink Movement - Pair One
timeFrame: 1 hour
measure: Post-blink Movement - Pair Two
timeFrame: Baseline
measure: Post-blink Movement - Pair Two
timeFrame: 1 hour
measure: Post-blink Movement - Pair Three
timeFrame: Baseline
measure: Post-blink Movement - Pair Three
timeFrame: 1 hour
measure: Post-blink Movement - Pair Four
timeFrame: Baseline
measure: Post-blink Movement - Pair Four
timeFrame: 1 hour
measure: Lens Tightness - Pair One
timeFrame: Baseline and 1 hour
measure: Lens Tightness - Pair Two
timeFrame: Baseline and 1 hour
measure: Lens Tightness - Pair Three
timeFrame: Baseline and 1 hour
measure: Lens Tightness - Pair Four
timeFrame: Baseline and 1 hour
measure: Overall Fit Preference - Pair One
timeFrame: Baseline and 1 hour
measure: Overall Fit Acceptance - Pair Two
timeFrame: Baseline and 1 hour
measure: Overall Fit Acceptance - Pair Three
timeFrame: Baseline and 1 hour
measure: Overall Fit Acceptance - Pair Four
timeFrame: Baseline and 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico D.F.
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
References: