Back to results

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Methafilcon A IV

Ocufilcon B

Omafilcon A

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Eurolens Research - The University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Methafilcon A IV

Ocufilcon B

Omafilcon A

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Lens Fit - Horizontal Centration

Assessment of horizontal centration of lens on eye

Lens Fit - Vertical Centration

Assessment of vertical centration of lens on eye

Lens Fit - Corneal Coverage of Lens

Assessment of corneal coverage of lens on eye

Lens Fit - Movement of Lens

Assessment of movement of lens on eye

Secondary Outcome Measures

Full Information

NCT ID

NCT03235115

First Posted

July 27, 2017

Last Updated

August 27, 2019

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03235115

Brief Title

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Official Title

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

June 23, 2017 (Actual)

Primary Completion Date

September 22, 2017 (Actual)

Study Completion Date

September 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methafilcon A IV

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ocufilcon B

Arm Type

Active Comparator

Arm Description

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

Arm Title

Omafilcon A

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Methafilcon A IV

Intervention Description

Contact Lens

Intervention Type

Device

Intervention Name(s)

Ocufilcon B

Intervention Description

Contact Lens

Intervention Type

Device

Intervention Name(s)

Omafilcon A

Intervention Description

Contact Lens

Primary Outcome Measure Information:

Title

Visual Acuity Using logMAR

Description

Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction

Time Frame