Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

CooperVision

Status

Completed

Conditions

Astigmatism

Treatments

Device: filcon IV1 toric lens

Device: ocufilcon D toric lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT02847169

EX-MKTG-66

Details and patient eligibility

About

The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

Full description

This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D hydrogel toric lenses.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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 toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.
- 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 (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule

Exclusion criteria

A person will be excluded from the study if he/she:
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.00 D 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 (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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
- 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.