Clinical trial NCT03098745: Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
Official title: Fitting Evaluation of Hydrogel and 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: 2017-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Detailed description: This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. 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 each pair bilaterally in a series of three short fitting comparisons.

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 who is not wearing any of the study lenses.
  * Has a CL spherical prescription between - 1.00 and - 6.00 (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:

* 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 (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: Visual Acuity
timeFrame: Baseline (lens insertion), 1 hour
measure: Comfort
timeFrame: Insertion, 1hr
measure: Lens Centration
timeFrame: Insertion
measure: Lens Centration
timeFrame: 1 Hour
measure: Post-blink Lens Movement
timeFrame: Insertion
measure: Post-blink Lens Movement
timeFrame: 1 Hour
measure: Lens Fit Acceptance
timeFrame: Insertion
measure: Lens Fit Acceptance
timeFrame: 1 Hour
measure: Lens Fit Preference
timeFrame: 1 Hour
measure: Limbal Redness
timeFrame: 1 Hour
measure: Bulbar Redness
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Optometry Clinic, National Autonomous University
Study officials:
affiliation: National Autonomous University, School of Optometry
name: Ruben Velázquez Guerrero, MSc., FIACLE
role: PRINCIPAL_INVESTIGATOR
References: