N/A Completed N=43 Other

Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

Source: ClinicalTrials.gov NCT03835221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcomePrimary: Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses — 40; 3; 0 Participants

Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	41; 1; 0	—
PRIMARY Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	41; 1; 0	—
PRIMARY Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	42; 0; 0	—
PRIMARY Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	42; 0; 0	—
PRIMARY Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	42; 0; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	100; 0	—
PRIMARY Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses	1.97	—
PRIMARY Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses	1.97	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	1.97	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	1.97	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	1.97	—
PRIMARY Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	1.55	—
PRIMARY Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	1.55	—
PRIMARY Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.47	—
PRIMARY Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.47	—
PRIMARY Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.47	—
PRIMARY Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	2.02	—
PRIMARY Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	2.02	—
PRIMARY Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.48	—
PRIMARY Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.48	—
PRIMARY Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	0.48	—
PRIMARY Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	3.8	—
PRIMARY Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	3.8	—
PRIMARY Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
PRIMARY Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
PRIMARY Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	3.8	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	3.8	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	4.0	—
SECONDARY Average Daily Wearing Time - Methafilcon A Toric Contact Lenses	10.4	—
SECONDARY Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	11.0	—
SECONDARY Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	11.0	—
SECONDARY Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses	7.6	—
SECONDARY Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	8.6	—
SECONDARY Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	8.6	—

Eligibility Criteria

Inclusion Criteria

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 contact lens wearer
Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 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

Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye
Has a history of not achieving comfortable Contact Lens (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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03835221). 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.