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: May 21, 2014
Last verified: May 2014
  Purpose

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.


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

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 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.


Secondary Outcome Measures:
  • Total Wettability Score [ Time Frame: Hour 8 ] [ Designated as safety issue: No ]
    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.


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
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 Name: 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 Name: 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 Name: Proclear® 1 day

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839318

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, PhD 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
Results First Received: May 21, 2014
Last Updated: May 21, 2014
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 July 20, 2014