Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

NCT03235115 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-85
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Methafilcon A IV

ACTIVE COMPARATOR

Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.

Device: Ocufilcon B; Device: Omafilcon A

Ocufilcon B

ACTIVE COMPARATOR

Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.

Device: Methafilcon A IV; Device: Omafilcon A

Omafilcon A

ACTIVE COMPARATOR

Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.

Device: Methafilcon A IV; Device: Ocufilcon B

Interventions

Methafilcon A IV DEVICE

Contact Lens

Ocufilcon B; Omafilcon A

Ocufilcon B DEVICE

Contact Lens

Methafilcon A IV; Omafilcon A

Omafilcon A DEVICE

Contact Lens

Methafilcon A IV; Ocufilcon B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, O.D., MSc., FAAO
• Organization: CooperVision

javega@coopervision.com

9256213761

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: June 23, 2017
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: September 12, 2019
• Results First Posted: November 14, 2018

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)