N/A
N=40
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03098745 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Visual Acuity — -0.04; -0.05; -0.03; -0.01 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omafilcon A (Device); Somofilcon A (Device); Omafilcon A - Proclear (PC) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.04; -0.05; -0.03; -0.01; -0.01; -0.01 | — |
| PRIMARY Comfort |
94.5; 98.0; 94.7; 95.8; 96.8; 93.7 | — |
| PRIMARY Lens Centration |
40; 40; 40; 0; 0; 0 | — |
| PRIMARY Lens Centration |
40; 40; 40; 0; 0; 0 | — |
| PRIMARY Post-blink Lens Movement |
0; 1; 0; 7; 1; 4 | — |
| PRIMARY Post-blink Lens Movement |
0; 1; 0; 7; 1; 4 | — |
| PRIMARY Lens Fit Acceptance |
0; 1; 0; 0; 0; 4 | — |
| PRIMARY Lens Fit Acceptance |
0; 1; 0; 0; 0; 4 | — |
| PRIMARY Lens Fit Preference |
5; 2; 6; 27 | — |
| PRIMARY Limbal Redness |
0.41; 0.39; 0.39 | — |
| PRIMARY Bulbar Redness |
0.51; 0.55; 0.50 | — |
Summary
The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.
Eligibility Criteria
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 CL (Contact Lens) wearer who is not wearing any of the study lenses.
- Has a CL spherical prescription between - 1.00 and - 6.00 (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
- A person will be excluded from the study if he/she:
- 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 - 6.00D
- 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.
Data sourced from ClinicalTrials.gov (NCT03098745). 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.