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

NCT ID: NCT01839318

Last Updated: 2014-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-06-30

Brief Summary

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.

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.

Conditions

Myopia; Hyperopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nelfilcon A contact lenses

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Etafilcon A contact lenses

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Omafilcon A contact lenses

Intervention Type: DEVICE

Interventions

Nelfilcon A contact lenses

Intervention Type: DEVICE

Omafilcon A contact lenses

Intervention Type: DEVICE

Etafilcon A contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES® AquaComfort Plus®; Proclear® 1 day; 1-DAY ACUVUE® MOIST®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessie Lemp, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

A01336

Identifier Type: -

Identifier Source: org_study_id