DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Myopia Clinical Trial

Official title:

Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157909
• Other study ID #: C-13-055
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: July 16, 2015
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• 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 is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign an Informed Consent Document;

• Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;

• Manifest cylinder less than or equal to 0.75 D;

• Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;

• Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;

• Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;

• Other protocol-defined criteria may apply.

Exclusion Criteria:

• Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear;

• History of herpetic keratitis;

• History of corneal or refractive surgery or irregular cornea;

• A pathologically dry eye that precludes contact lens wear;

• Monocular (only one eye with functional vision);

• Monovision correction;

• History of intolerance or hypersensitivity to any component of the test articles or associated materials;

• Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;

• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B sphere modified design contact lenses

• Lotrafilcon B sphere contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes	With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.	Dispense (Day 0), Week 1	No