Clinical trial NCT02131402: Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses
Official title: Non-Dispensing Fitting Study Comparing the Clinical Performance of Hydrogel vs. Silicone 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: 2014-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

Detailed description: This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

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 CL (Contact Lens) wearer
* Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (Diopter) 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:

* 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 -10.00D
* 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 (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: Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
timeFrame: Baseline
measure: Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
timeFrame: Baseline
measure: Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
timeFrame: Baseline
measure: Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
timeFrame: 1 hours post settling
measure: Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
timeFrame: Baseline
measure: Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
timeFrame: Baseline
measure: Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
timeFrame: Baseline
measure: Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
timeFrame: Baseline
measure: Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
timeFrame: Baseline
measure: Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
timeFrame: Baseline
measure: Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D
timeFrame: 1 hour post settling
measure: Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A
timeFrame: 1 hour post settling
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Optometry Research Group (GIO) Optics Department, University of Valencia
Study officials:
affiliation: Optics Department, University of Valencia
name: Robert Montés-Mico, OD MPhil PhD
role: PRINCIPAL_INVESTIGATOR
References: