Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

Alcon Research30 enrolled

Overview

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Myopia Hyperopia Refractive Error

Interventions

Nelfilcon A contact lensesDEVICE

Omafilcon A contact lensesDEVICE

Etafilcon A contact lensesDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign Informed Consent. * Adapted soft contact lens wearer. * Willing to wear contact lenses up to 12 hours and attend all study visits. * Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1. * Contact lens prescription within the power range specified in the protocol. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * Any use of systemic or ocular medications that would contraindicate contact lens wear. * Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear. * Monocular (only 1 eye with functional vision) or fit with only 1 lens. * History of herpetic keratitis, ocular surgery, or irregular cornea. * Known pregnancy. * Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses. * Participation in any clinical study within 30 days of Visit 1. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours

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 contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

Time frame: Hour 8

Secondary Outcomes

Total Wettability Score

The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.

Time frame: Hour 8

Data from ClinicalTrials.gov

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