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

Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia; Hyperopia
• Intervention / Treatment: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses; Device: Omafilcon A contact lenses

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAILIES AquaComfort Plus; Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort Plus®
Active Comparator: 1-DAY ACUVUE MOIST; Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Etafilcon A contact lenses; Other Names: 1-DAY ACUVUE® MOIST®
Active Comparator: Proclear 1 day; Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.	Device: Omafilcon A contact lenses; Other Names: Proclear® 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hour 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hour 8

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jessie Lemp, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Daily disposable contact lenses; Soft contact lenses; Tear Film Break Up Time; Contact lens wettability
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: A01336