Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01614600
First received: June 6, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).


Condition Intervention
Dry Eye Syndrome
Myopia
Device: Nelfilcon A contact lenses

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 [ Time Frame: Baseline, Week 1, Week 2 ] [ Designated as safety issue: No ]
    Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.


Enrollment: 88
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAILIES® AquaComfort Plus®
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Device: Nelfilcon A contact lenses
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
  • Identified as symptomatic using a baseline screening questionnaire.
  • Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
  • Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Neophytes and current wearers of daily disposable contact lenses.
  • Requires monovision correction.
  • Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • A history of ocular surgery/trauma within the last 6 months.
  • Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • 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: NCT01614600

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern, MBA, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01614600     History of Changes
Other Study ID Numbers: A00849
Study First Received: June 6, 2012
Results First Received: September 27, 2013
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
contact lens
dry eye syndrome
symptomatic
daily disposable
myopia

Additional relevant MeSH terms:
Syndrome
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on September 18, 2014