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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614600
• Other study ID #: A00849
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: September 27, 2013
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Myopia

Intervention

Device:
• Nelfilcon A contact lenses
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2	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.	Baseline, Week 1, Week 2	No