N/A
Completed N=35
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Source: ClinicalTrials.gov NCT02727816 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Centration - Pair One — 35; 35; 0; 0 number of eyes
Summary
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Centration - Pair One |
35; 35; 0; 0; 0; 0 | — |
| PRIMARY Centration - Pair Two |
35; 35; 0; 0; 0; 0 | — |
| PRIMARY Centration - Pair Three |
35; 35; 0; 0; 0; 0 | — |
| PRIMARY Centration - Pair Four |
35; 35; 0; 0; 0; 0 | — |
| PRIMARY Post-blink Movement - Pair One |
2; 0; 19; 9; 14; 26 | — |
| PRIMARY Post-blink Movement - Pair Two |
4; 1; 5; 13; 23; 20 | — |
| PRIMARY Post-blink Movement - Pair Three |
0; 0; 10; 5; 24; 28 | — |
| PRIMARY Post-blink Movement - Pair Four |
3; 1; 7; 10; 25; 24 | — |
| PRIMARY Lens Tightness - Pair One |
62.8; 57.1; 64.9; 57.1 | — |
| PRIMARY Lens Tightness - Pair Two |
57.0; 52.3; 57.7; 56.6 | — |
| PRIMARY Lens Tightness - Pair Three |
54.0; 54.3; 54.3; 51.2 | — |
| PRIMARY Lens Tightness - Pair Four |
61.1; 66.7; 56.3; 56.6 | — |
| PRIMARY Overall Fit Preference - Pair One |
4; 15; 16; 3; 17; 15 | — |
| PRIMARY Overall Fit Acceptance - Pair Two |
13; 9; 13; 13; 6; 16 | — |
| PRIMARY Overall Fit Acceptance - Pair Three |
12; 6; 17; 6; 10; 19 | — |
| PRIMARY Overall Fit Acceptance - Pair Four |
9; 5; 21; 12; 8; 15 | — |
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.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopters) 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 (GPC) 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 (NCT02727816). 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. Informational only — not medical advice.