Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

NCT ID: NCT02089191

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

DACP/MyDay

Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Group Type: OTHER

Nelfilcon A contact lenses

Intervention Type: DEVICE

Stenfilcon A contact lenses

Intervention Type: DEVICE

MyDay/DACP

Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.

Group Type: OTHER

Nelfilcon A contact lenses

Intervention Type: DEVICE

Stenfilcon A contact lenses

Intervention Type: DEVICE

Interventions

Nelfilcon A contact lenses

Intervention Type: DEVICE

Stenfilcon A contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES® AquaComfort Plus®; DACP; MyDay®

Eligibility Criteria

Inclusion Criteria

• Must sign an Informed Consent form;
• Adapted, current soft contact lens wearer;
• Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
• Cylinder ≤ -1.00 D in both eyes at Visit 1;
• Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
• Willing to wear study lenses up to 12 hours and attend all study visits;
• Able to be successfully fitted with study lenses;
• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;

Exclusion Criteria

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Use of artificial tears and rewetting drops during the study;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Any abnormal ocular condition observed during Visit 1;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Participation in any clinical study within 30 days of Visit 1;
• Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;

• 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

Global Medical Affairs, Clinical Manager, Vision Care

Role: STUDY_DIRECTOR

Alcon Research

Locations

Alcon Investigative Site

Jena, , Germany

Countries

Germany

Other Identifiers

M-14-006

Identifier Type: -

Identifier Source: org_study_id