Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548833
• Other study ID #: A00924
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: June 6, 2013
• Start date: March 2012
• Est. completion date: April 2012

Study information

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

Clinical Trial Summary

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.

• Require vision correction in both eyes.

• Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder =0.75 diopter, no ADD correction.

• Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.

• Willing and able to wear study contact lenses 16 hours per day.

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

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.

• Require monovision correction.

• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.

• Ocular surgery/trauma within the last 6 months.

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

• Topical ocular or systemic corticosteroid use within 14 days of enrollment.

• Pregnant and nursing women.

• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
• Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
• Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alcon Research	Aston University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)	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 corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.	Day 7, 16 hours after lens insertion	No