Daily Disposable Contact Lens Tear Film Study

CIBA VISION9 enrolled

Overview

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

delefilcon A contact lensDEVICE

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

narafilcon A contact lensDEVICE

Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be of legal age of consent and sign Informed Consent document. * Willing and able to wear spherical contact lenses for 16 hours. * Willing and able to wear spherical contact lenses within the available range of powers. * Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Anterior segment infection, inflammation, or abnormality. * Any use of systemic medications for which contact lens wear could be contraindicated. * History of refractive surgery or irregular cornea. * Currently enrolled in any clinical trial. * Eye injury within twelve weeks prior to enrollment. * Other protocol-defined exclusion criteria may apply.

Locations (1)

Aston University

Birmingham, United Kingdom

Outcomes

Primary Outcomes

Number of Participants With Corrected Visual Acuity of 0.0 or Better

Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.

Time frame: Up to 16 hours after lens insertion

Pre-Lens Noninvasive Tear Break-Up Time

The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.

Time frame: Up to 16 hours after lens insertion

Average Tear Meniscus Height

The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.

Time frame: Up to 16 hours after lens insertion

Average Ocular Surface Temperature

Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.

Time frame: Up to 16 hours after lens insertion

Secondary Outcomes

Subjective Comfort

Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, "How comfortable is the lens feeling at present?"

Data from ClinicalTrials.gov

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