Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Ocufilcon B; Device: Omafilcon A; Device: Methafilcon A IV

Detailed Description

This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research - The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methafilcon A IV; Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.	Device: Ocufilcon B; Contact Lens; Device: Omafilcon A; Contact Lens
Active Comparator: Ocufilcon B; Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.	Device: Omafilcon A; Contact Lens; Device: Methafilcon A IV; Contact Lens
Active Comparator: Omafilcon A; Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.	Device: Ocufilcon B; Contact Lens; Device: Methafilcon A IV; Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity Using logMAR	Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Horizontal Centration	Assessment of horizontal centration of lens on eye	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Vertical Centration	Assessment of vertical centration of lens on eye	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Corneal Coverage of Lens	Assessment of corneal coverage of lens on eye	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Movement of Lens	Assessment of movement of lens on eye	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): September 22, 2017
• Study Completion (Actual): September 22, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Refractive Errors; Seizures; Myopia
• Other Study ID Numbers: EX-MKTG-85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes