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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01130974
First received: May 25, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Myopia
Device: Bausch & Lomb contact lens
Device: Marketed daily disposable contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: Summarized over all follow-up visits through 1 month ] [ Designated as safety issue: No ]
    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

  • logMAR Visual Acuity (VA) [ Time Frame: Summarized over all visits, and dispensed visit ] [ Designated as safety issue: No ]
    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

  • logMAR Visual Acuity (VA) [ Time Frame: 2 week and 1 month follow-up ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Lens Wettability [ Time Frame: Summarized over all follow-up visits through 1 month ] [ Designated as safety issue: No ]
    Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.

  • Lens Deposits [ Time Frame: Summarized over all follow-up visits through one month ] [ Designated as safety issue: No ]
    Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month

  • Lens Centration [ Time Frame: Summarized over all follow-up visits through 1 month ] [ Designated as safety issue: No ]

    Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).

    Suboptimal lens centration was defined as a rating other than excellent.


  • Lens Movement [ Time Frame: Summarized over all follow-up visits through one month ] [ Designated as safety issue: No ]
    Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.

  • Symptoms & Complaints [ Time Frame: Summarized over all follow-up visits through one month ] [ Designated as safety issue: No ]
    Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.


Enrollment: 200
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bausch & Lomb contact lens
Bausch & Lomb daily disposable cosmetic tint contact lens
Device: Bausch & Lomb contact lens
Bausch & Lomb daily disposable cosmetic tint contact lens
Active Comparator: Marketed daily disposable contact lens
Marketed daily disposable cosmetic tint contact lens
Device: Marketed daily disposable contact lens
Marketed daily disposable cosmetic tint contact lens

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130974

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Bev Barna Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01130974     History of Changes
Other Study ID Numbers: 639
Study First Received: May 25, 2010
Results First Received: March 15, 2013
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014