Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Myopia Clinical Trial

Official title:

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235115
• Other study ID #: EX-MKTG-85
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: September 22, 2017

Study information

• Verified date: August 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 22, 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Seizures

Intervention

Device:
• Methafilcon A IV
Contact Lens
• Ocufilcon B
Contact Lens
• Omafilcon A
Contact Lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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