Clinical Performance of Stenfilcon A Versus Filcon II 3
Status
Completed
Conditions
Myopia
Treatments
Device: filcon II 3
Device: stenfilcon A
Details and patient eligibility
About
Clinical Performance of Stenfilcon vs. Filcon II 3
Full 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.
Enrollment
60 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
60 participants in 2 patient groups
stenfilcon A
Experimental group
Description:
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Treatment:
Device: filcon II 3
filcon II 3
Active Comparator group
Description:
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Treatment:
Device: stenfilcon A
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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