A Clinical Performance of Two Soft Toric Contact Lenses

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: Lens 1 (omafilcon B); Device: Lens 2 (fanfilcon A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05633082

EX-MKTG-143

Details and patient eligibility

About

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Full description

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• They are of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.
• They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
• They are expected to be able to be fitted with the study lenses within the power range available.

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 are aphakic.
• 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 an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
• They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lens 1

Experimental group

Description:

All participants wore Lens 1 for 15 minutes (Period 1)

Treatment:

Device: Lens 1 (omafilcon B)

Lens 2

Experimental group

Description:

All participants wore Lens 2 for 15 minutes (Period 2)

Treatment:

Device: Lens 2 (fanfilcon A)