N/A N=40 Randomized Double-blind Treatment

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT03235115 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Visual Acuity Using logMAR — -0.14; -0.13; -0.13; -0.14 logMAR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Methafilcon A IV (Device); Ocufilcon B (Device); Omafilcon A (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity Using logMAR	-0.14; -0.13; -0.13; -0.14; -0.14; -0.14	—
PRIMARY Lens Fit - Horizontal Centration	0; 0; 0; 1; 1; 1	—
PRIMARY Lens Fit - Vertical Centration	0; 0; 0; 12; 6; 9	—
PRIMARY Lens Fit - Corneal Coverage of Lens	0; 0; 0; 6; 16; 4	—
PRIMARY Lens Fit - Movement of Lens	0; 0; 0; 1; 7; 8	—

Summary

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Eligibility Criteria

Inclusion Criteria

They are of aged 18-40 and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.

Exclusion Criteria

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or lactating.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03235115). 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.