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Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Sponsored by CooperVision, Inc.

About this trial

Last updated 9 years ago

Study ID

EX-MKTG-47

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 40 Years
All Sexes

Trial Timing

Ended 12 years ago

What is this trial about?

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

What are the participation requirements?

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.