Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561560
• Other study ID #: P-347-C-019
• Status: Completed
• Phase: N/A
• First received: March 21, 2012
• Last updated: November 19, 2013
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeFinland: Ethics CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign written Informed Consent Document.

• Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.

• Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.

• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.

• Willing to wear study lenses for at least eight hours per day and at least five days per week.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Has not worn contact lenses before.

• Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.

• Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.

• Ocular surgery/trauma within the last six months.

• Topical ocular or systemic use of antibiotics within seven days of enrollment.

• Pregnant or nursing women.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
• Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-of-day Comfort	End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).	Week 2	No