N/A
Completed N=30
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Astigmatism
Source: ClinicalTrials.gov NCT02847169 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Overall Fit Acceptance — 3.8; 3.5; 3.7; 3.8 units on a scale
Summary
The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Fit Acceptance |
3.8; 3.5; 3.7; 3.8; 3.7 | — |
| PRIMARY Lens Centration |
100; 0; 0; 100; 0; 0 | — |
| PRIMARY Post-blink Movement |
1.97; 2.1; 2.1; 2.0; 2.2 | — |
| PRIMARY Overall Stability |
3.8; 3.6; 3.8; 3.7; 3.7 | — |
| PRIMARY Corneal Coverage |
29; 29; 0; 0; 29; 29 | — |
| PRIMARY Lens Orientation in Primary Position of Gaze |
62; 72; 76; 79; 79; 35 | — |
| PRIMARY Rotational Recovery in Degrees After 60 Seconds |
4.1; 5.0; 3.3; 2.2; 3.8 | — |
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 toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.
- 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 (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria
- A person will be excluded from the study if he/she:
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
- 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 (NCT02847169). 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.