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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01839318
First received: April 22, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

The purpose of this study is 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 will be assessed. Each participant will wear three brands of contact lenses in a randomized, cross-over fashion.


Condition Intervention
Myopia
Hyperopia
Refractive Error
Device: Nelfilcon A contact lens
Device: Omafilcon A contact lens
Device: Etafilcon A contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours [ Time Frame: Hour 8 ] [ Designated as safety issue: No ]
    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 will be projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection will be observed. PL NIK-BUT is recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film.


Secondary Outcome Measures:
  • Total wettability score [ Time Frame: Hour 8 ] [ Designated as safety issue: No ]
    The investigator will grade 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 will be calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal).


Enrollment: 30
Study Start Date: April 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAILIES AquaComfort Plus
DAILIES AquaComfort Plus worn first, followed by 1-DAY ACUVUE MOIST and Proclear 1 day in randomized order. Each product worn for 1 day, 12 hours.
Device: Nelfilcon A contact lens
Other Name: DAILIES® AquaComfort Plus®
Active Comparator: 1-DAY ACUVUE MOIST
1-DAY ACUVUE MOIST worn first, followed by DAILIES AquaComfort Plus and Proclear 1 day in randomized order. Each product worn for 1 day, 12 hours.
Device: Etafilcon A contact lens
Other Name: 1-DAY ACUVUE® MOIST®
Active Comparator: Proclear 1 day
Proclear 1 day worn first, followed by 1-DAY ACUVUE MOIST and DAILIES AquaComfort Plus in randomized order. Each product worn for 1 day, 12 hours.
Device: Omafilcon A contact lens
Other Name: Proclear® 1 day

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign Informed Consent.
  • Adapted 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.
  • 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 subjects (only one eye with functional vision) or subjects fit with only one lens.
  • Known pregnancy.
  • Participation in any clinical study within 30 days of Visit 1.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839318

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01839318     History of Changes
Other Study ID Numbers: A01336
Study First Received: April 22, 2013
Last Updated: June 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Alcon Research:
Soft contact lenses
Daily disposable contact lenses
Tear Film Break Up Time
Contact lens wettability

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014