N/A N=20 Randomized Double-blind Treatment

Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT01966770 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Visual Acuity (VA) logMAR (Habitual Lenses) — -0.06 LogMar

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pair 1 (ocufilcon D / ocufilcon D) (Device); Pair 2 (ocufilcon D / enfilcon A) (Device); Pair 3 (ocufilcon D / comfilcon A) (Device); Pair 4 (methafilcon A / methafilcon A) (Device); Pair 5 (methafilcon A / comfilcon A) (Device); Pair 6 (omafilcon A / comfilcon A) (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity (VA) logMAR (Habitual Lenses)	-0.06	—
PRIMARY Visual Acuity (VA) logMAR (Study Lenses)	-0.13; -0.11; -0.13; -0.12; -0.13; -0.11	—
PRIMARY Comfort Contact Lens Insertion (Day 1 Study Lenses)	92; 95; 95; 97; 95; 96	—
PRIMARY Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)	97; 96; 96; 96; 96; 95	—
PRIMARY Comfort Contact Lens Insertion (Day 2 Study Lenses)	94; 92; 93; 96; 94; 97	—
PRIMARY Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)	96; 93; 94; 96; 97; 98	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)	5; 35; 60	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)	0; 15; 85	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)	10; 20; 70	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	10; 5; 85	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	0; 10; 90	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	10; 5; 85	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)	20; 10; 70	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)	10; 15; 75	—
PRIMARY Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)	5; 15; 80	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	10; 15; 75	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	10; 10; 80	—
PRIMARY Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	0; 20; 80	—
PRIMARY Lens Fitting Characteristics, Centration (Habitual Lens)	75	—
PRIMARY Lens Fitting Characteristics, Tightness (Habitual Lens)	46	—
PRIMARY Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)	0.21; 0.19	—
PRIMARY Lens Fitting Characteristics, Centration (Day 1 Study Lenses)	100; 100; 100; 100; 100; 90	—
PRIMARY Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)	50; 48; 51; 45; 52; 54	—
PRIMARY Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)	0.00; 0.00; 0.00; 0.05; 0.00; 0.00	—
PRIMARY Lens Fitting Characteristics, Centration (Day 2 Study Lenses)	95; 95; 95; 100; 100; 100	—
PRIMARY Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)	53; 50; 51; 53; 53; 55	—
PRIMARY Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)	0.11; 0.14; 0.13; 0.05; 0.33; 0.00	—
PRIMARY Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	5; 10; 85	—
PRIMARY Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	15; 5; 80	—
PRIMARY Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	5; 10; 85	—
PRIMARY Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	5; 5; 90	—
PRIMARY Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	10; 40; 50	—
PRIMARY Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	5; 35; 60	—
PRIMARY Overall Ease of Lens Handling (Day 1 Study Lenses)	95; 95; 95; 93; 94; 92	—
PRIMARY Overall Ease of Lens Handling (Day 2 Study Lenses)	96; 96; 96; 94; 94; 94	—

Summary

The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

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 contact lens wearer
Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
Has a spectacle cylinder up to 0.75D (diopter) in each eye
Is correctable to a visual acuity of 20/25 or better in both eyes
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter
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 contact lens wear (5 days per week; > 8 hours/day)
Has a contact lens prescription outside the range of -1.00 to -6.00D
Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
Has best corrected spectacle distance vision worse than 20/25 in either eye
Has any systemic or topical medications that will affect ocular health
Has any ocular pathology or severe insufficiency of lacrimal secretion
Has persistent, clinically significant corneal or conjunctival staining
Has active neovascularization or any central corneal scars
Is aphakic
Is presbyopic
Has undergone corneal refractive surgery
Is participating in any other type of eye related conical or research study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01966770). 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.