N/A N=60 Randomized Double-blind Other

Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT02131402 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A — 97; 84 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ocufilcon D (Device); omafilcon A (Device); methafilcon A (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A	97; 84	—
PRIMARY Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D	96; 90	—
PRIMARY Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A	97; 86	—
PRIMARY Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	94; 82	—
PRIMARY Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	98; 76	—
PRIMARY Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	96; 78	—
PRIMARY Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A	98; 76	—
PRIMARY Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D	96; 83	—
PRIMARY Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A	96; 78	—
PRIMARY Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A	66.7; 0.0; 16.7; 0.0; 10.0; 0.0	—
PRIMARY Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D	38; 0; 22; 0; 35; 0	—
PRIMARY Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A	55.0; 0.0; 18.3; 0.0; 18.3; 0.0	—
PRIMARY Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A	67; 0; 20; 0; 13; 0	—
PRIMARY Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D	42; 0; 18; 0; 35; 0	—
PRIMARY Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A	53; 0; 22; 0; 18; 0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A	2.0; 2.0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D	2.0; 2.0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A	2.0; 2.0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A	50; 50	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D	50; 50	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A	50; 50	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A	100; 100; 0; 0; 0; 0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D	100; 100; 0; 0; 0; 0	—
PRIMARY Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A	100; 100; 0; 0; 0; 0	—
PRIMARY Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	2.6; 18	—
PRIMARY Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	3.3; 11	—
PRIMARY Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	2.0; 15	—
PRIMARY Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A	0.6; 8.8	—
PRIMARY Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D	1.4; 8.8	—
PRIMARY Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A	1.2; 13	—
PRIMARY Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A	-0.041; -0.035	—
PRIMARY Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D	-0.041; -0.040	—
PRIMARY Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A	-0.041; -0.043	—

Summary

The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

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 CL (Contact Lens) wearer
Has a CL spherical prescription between - 1.00 and - 10.00 (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

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 -10.00D
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02131402). 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.