N/A
N=60
Clinical Performance of Stenfilcon A Versus Filcon II 3
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01808209 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Daily and Comfortable Wearing Time — 9.8; 7.7 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stenfilcon A (Device); filcon II 3 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily and Comfortable Wearing Time |
11.4; 10.8; 8.7; 8.7 | — |
| PRIMARY Daily and Comfortable Wearing Time |
11.4; 10.8; 8.7; 8.7 | — |
| PRIMARY Handling |
90.8; 92.2; 84.9; 86.4; 93.4; 89.3 | — |
| PRIMARY Comfort |
93.0; 90.6; 89.7; 88.8; 81.7; 79.0 | — |
| PRIMARY Comfort |
93.0; 90.6; 89.7; 88.8; 81.7; 79.0 | — |
| PRIMARY Dryness |
94.4; 93.6; 88.9; 88.0; 78.5; 79.2 | — |
| PRIMARY Dryness |
94.4; 93.6; 88.9; 88.0; 78.5; 79.2 | — |
| PRIMARY Vision Quality |
89.9; 89.0 | — |
| PRIMARY Vision Quality |
89.9; 89.0 | — |
| PRIMARY Eye Whiteness |
85.3; 84.9 | — |
| PRIMARY Eye Whiteness |
85.3; 84.9 | — |
| PRIMARY Overall Satisfaction |
85.7; 82.5 | — |
| PRIMARY Overall Satisfaction |
85.7; 82.5 | — |
| PRIMARY Visual Acuity logMAR |
-0.06; -0.03 | — |
| PRIMARY Visual Acuity logMAR |
-0.06; -0.03 | — |
| PRIMARY Visual Acuity logMAR |
-0.06; -0.03 | — |
| PRIMARY Wettability |
10.9; 9.2; 11.6; 9.6 | — |
| SECONDARY Blood Vessel Coverage |
4.63; 4.41; 5.00; 5.25 | — |
| SECONDARY Blood Vessel Coverage |
4.63; 4.41; 5.00; 5.25 | — |
| SECONDARY Conjunctival Redness |
35.6; 35.4; 35.8; 35.4 | — |
| SECONDARY Conjunctival Redness |
35.6; 35.4; 35.8; 35.4 | — |
| SECONDARY Corneal Staining |
0.4; 0.5 | — |
| SECONDARY Corneal Staining |
0.4; 0.5 | — |
| SECONDARY Conjunctival Staining |
0.6; 0.6 | — |
Summary
Clinical Performance of Stenfilcon vs. Filcon II 3
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
Data sourced from ClinicalTrials.gov (NCT01808209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.