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

• ClinicalTrials.gov Identifier: NCT02089191
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Results First Posted: May 15, 2015
• Last Update Posted: May 15, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: March 14, 2014
• First Posted Date: March 17, 2014
• Results First Submitted Date: April 30, 2015
• Results First Posted Date: May 15, 2015
• Last Update Posted Date: May 15, 2015
• Study Start Date: March 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2015)

Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear [ Time Frame: Day 1, Hour 12, each period ]

The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.

Original Primary Outcome Measures (submitted: March 14, 2014)

Time to 15% Distortion After 12 Hours [ Time Frame: Hour 12 ]

Time from first eye opening to 15% distortion of the ring mires projected onto the tear film. The right eye will be used for the analysis.

Current Secondary Outcome Measures (submitted: April 30, 2015)

Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear [ Time Frame: Hour 12 ]

The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.

Original Secondary Outcome Measures (submitted: March 14, 2014)

Speed of Tear Film Break Up at 15 Seconds After 12 Hours [ Time Frame: Hour 12 ]

The slope of the regression line (distorted areas vs. time) will be calculated. The right eye will be used for the analysis.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses
• Official Title: Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Refractive Error

Intervention

• Device: Nelfilcon A contact lenses
  Other Names:

  • DAILIES® AquaComfort Plus®
  • DACP
• Device: Stenfilcon A contact lenses
  Other Name: MyDay®

Study Arms

• 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.
  Interventions:

  • Device: Nelfilcon A contact lenses
  • Device: Stenfilcon A contact lenses
• 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.
  Interventions:

  • Device: Nelfilcon A contact lenses
  • Device: Stenfilcon A contact lenses

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2014): 31
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

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;
• 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 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;
• Other protocol-defined exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT02089191
• Other Study ID Numbers: M-14-006
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alcon Research
• Study Sponsor: Alcon Research
• Collaborators: Not Provided

Investigators

• Study Director: Global Medical Affairs, Clinical Manager, Vision Care; Alcon Research

• PRS Account: Alcon Research
• Verification Date: April 2015