N/A Completed N=39 Other

Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

Source: ClinicalTrials.gov NCT03835078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcomePrimary: Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses — 100; 0; 0 percentage of participants

Summary

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	100; 0; 0	—
PRIMARY Percentage of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Contact Lenses	100; 0; 0	—
PRIMARY Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0; 0	—
PRIMARY Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0; 0	—
PRIMARY Percentage of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0	—
PRIMARY Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Contact Lenses	100; 0	—
PRIMARY Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	1.95	—
PRIMARY Post-blink Movement Assessment by the Investigator - Methafilcon A Contact Lenses	1.95	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	2.0	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	2.0	—
PRIMARY Post-blink Movement Assessment by the Investigator - Fanfilcon A Contact Lenses	2.0	—
PRIMARY Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	52.31	—
PRIMARY Lens Tightness Assessment by the Investigator - Methafilcon A Contact Lenses	52.31	—
PRIMARY Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.51	—
PRIMARY Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.51	—
PRIMARY Lens Tightness Assessment by the Investigator - Fanfilcon A Contact Lenses	50.51	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	3.74	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Methafilcon A Contact Lenses	3.74	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.95	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.95	—
PRIMARY Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Contact Lenses	3.95	—
SECONDARY Average Daily Wearing Time - Methafilcon A Contact Lenses	12.1	—
SECONDARY Average Daily Wearing Time - Fanfilcon A Contact Lenses	12.3	—
SECONDARY Average Daily Wearing Time - Fanfilcon A Contact Lenses	12.3	—
SECONDARY Average Comfortable Wearing Time - Methafilcon A Contact Lenses	10.0	—
SECONDARY Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	9.7	—
SECONDARY Average Comfortable Wearing Time - Fanfilcon A Contact Lenses	9.7	—

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 - 0.25 to - 8.00 (inclusive)
Have no less than -0.75D (Diopter) of astigmatism 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 of ≥ 1.00D (Diopter) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03835078). 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.