DAILIES TOTAL1® Lens Centration in a Japanese Population

Myopia Clinical Trial

Official title:

Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252133
• Other study ID #: ALJ-V2014-1
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: December 24, 2015
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Sign Informed Consent document.

• Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.

• Symptoms of contact lens discomfort as defined by protocol.

• Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.

• Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.

• Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.

• Acceptable contact lens fit with both study contact lenses.

• Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing DT1 or 1DAVTE.

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.

• Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.

• Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.

• History of herpetic keratitis, ocular surgery or irregular cornea.

• Prior refractive surgery (e.g. LASIK, PRK, etc).

• Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.

• Judged ineligible as a patient in this clinical study by the investigator.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses
Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
• Narafilcon A contact lenses
Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Locations

Country	Name	City	State
Japan	Contact Alcon Japan Ltd. for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of Lens Centration After 7 ± 2 Days of Wear	Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.	Day 7, each product	No