A Prospective Study of Two Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636986
• Other study ID #: A00930
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: November 25, 2013
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: November 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 performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Description:

Three study visits occurred over the course of 28 ± 3 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Be of legal age of consent and sign written Informed Consent Document and HIPAA form.

• Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.

• Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).

• Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.

• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.

• Willing and able to follow instructions and maintain the appointment schedule.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.

• Requires monovision or presbyopic correction.

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

• Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.

• Clinically significant lash or lid abnormality.

• Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.

• History of ocular surgery/trauma within the last 6 months.

• Topical or systemic antibiotics use within 7 days of enrollment.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lenses
Silicone hydrogel contact lenses for daily wear, daily disposable use
• Etafilcon A contact lenses
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 Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ	Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.	Day 0, Week 4	No