Clinical trial NCT01808209: Clinical Performance of Stenfilcon A Versus Filcon II 3
Official title: Clinical Performance of Stenfilcon A Versus Filcon II 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Clinical Performance of Stenfilcon vs. Filcon II 3

Detailed description: The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Eligibility criteria: Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

* Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
* Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
* Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
* Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
* Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
* An existing soft contact lens wearer of any modality.
* Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
* No amblyopia.
* No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
* No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
* No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
* No aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

* Neophytes, who have not worn lenses before
* Greater than 0.75D of refractive astigmatism in either eye
* Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* Presence of ocular or systemic disease or need of medication 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 the limbus
* Giant papillary conjunctivitis (GPC) Grade 3 or above
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, seborrheic conjunctivitis
* History of corneal ulcer or fungal infections
* Poor personal hygiene
* A known history of corneal hypoesthesia (reduced corneal sensitivity).
* Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
* Aphakia, Keratoconus or a highly irregular cornea

Primary outcomes:
measure: Daily and Comfortable Wearing Time
timeFrame: Baseline
measure: Daily and Comfortable Wearing Time
timeFrame: 1 week
measure: Handling
timeFrame: 1 Week
measure: Comfort
timeFrame: Baseline
measure: Comfort
timeFrame: 1 Week
measure: Dryness
timeFrame: Baseline
measure: Dryness
timeFrame: 1 Week
measure: Vision Quality
timeFrame: Baseline
measure: Vision Quality
timeFrame: 1 Week
measure: Eye Whiteness
timeFrame: Baseline
measure: Eye Whiteness
timeFrame: 1 Week
measure: Overall Satisfaction
timeFrame: Baseline
measure: Overall Satisfaction
timeFrame: 1 Week
measure: Visual Acuity logMAR
timeFrame: Baseline
measure: Visual Acuity logMAR
timeFrame: Dispense
measure: Visual Acuity logMAR
timeFrame: 1 Week
measure: Wettability
timeFrame: 1 Week
Secondary outcomes:
measure: Blood Vessel Coverage
timeFrame: Baseline
measure: Blood Vessel Coverage
timeFrame: 1 Week
measure: Conjunctival Redness
timeFrame: Baseline
measure: Conjunctival Redness
timeFrame: 1 Week
measure: Corneal Staining
timeFrame: Baseline
measure: Corneal Staining
timeFrame: 1 Week
measure: Conjunctival Staining
timeFrame: 1 Week
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Aston
state: West Midlands
Study officials:
affiliation: University of Aston Birmingham, West Midlands, United Kingdom
name: James Wolffsohn, PhD
role: PRINCIPAL_INVESTIGATOR
References: