Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism

Coopervision, Inc.1 site in 1 country59 target enrollmentSeptember 28, 2021

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: Coopervision, Inc.
Enrollment: 59
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.

Detailed Description

This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

Registry

clinicaltrials.gov

Start Date

September 28, 2021

End Date

June 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects will only be eligible for the study if:
•They are of legal age between 18 and 40 years.
•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 are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
•They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
•They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
•They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
•They can be fitted satisfactorily with both lens types.
•They own an acceptable pair of spectacles.

Exclusion Criteria

•Subjects will not be eligible to take part in the study 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 corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•They are pregnant or breastfeeding.
•They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
•They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
•They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: After 30 minutes of dispense (High Contrast VA)

Visual acuity was assessed using logMAR for each intervention.

Secondary Outcomes

Slit Lamp Biomicroscopy Findings - Corneal Staining(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Corneal Oedema(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Conjunctival Staining(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Conjunctival Redness(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Limbal Redness(At Exit (After 30 minutes in each of three interventions))
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(At Exit (After 30 minutes in each of three interventions))