A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

NCT01130974 | Completed Results

• 1 other identifier: 639
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Slit Lamp Findings

  Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) \> grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe

  Summarized over all follow-up visits through 1 month

• logMAR Visual Acuity (VA)

  Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit

  Summarized over all visits, and dispensed visit

• logMAR Visual Acuity (VA)

  Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit

  2 week and 1 month follow-up

Secondary Outcomes (5)

• Lens Wettability

  Summarized over all follow-up visits through 1 month

• Lens Deposits

  Summarized over all follow-up visits through one month

• Lens Centration

  Summarized over all follow-up visits through 1 month

• Lens Movement

  Summarized over all follow-up visits through one month

• Symptoms & Complaints

  Summarized over all follow-up visits through one month

Study Arms (2)

Bausch & Lomb contact lens

EXPERIMENTAL

Bausch \& Lomb daily disposable cosmetic tint contact lens

Device: Bausch & Lomb contact lens

Marketed daily disposable contact lens

ACTIVE COMPARATOR

Marketed daily disposable cosmetic tint contact lens

Device: Marketed daily disposable contact lens

Interventions

Bausch & Lomb contact lens DEVICE

Bausch \& Lomb daily disposable cosmetic tint contact lens

Bausch & Lomb contact lens

Marketed daily disposable contact lens DEVICE

Marketed daily disposable cosmetic tint contact lens

Marketed daily disposable contact lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must be of Asian descent.
• Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

You may not qualify if:

• Subjects who have any systemic disease affecting ocular health.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects with an active ocular disease or are using any ocular medication.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
• Subjects who currently wear monovision, multifocal, or toric contact lenses.
• Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Steffen
• Organization: Bausch & Lomb Inc.

robert.steffens@bausch.com

(585) 338-6399

Study Officials

• Bev Barna

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 10, 2013
• Results First Posted: December 10, 2013

Record last verified: 2013-11

Locations

US (1)