NCT01230554CompletedNot Applicable
A Study to Assess the Product Performance of a Daily Disposable Contact Lens
Bausch & Lomb Incorporated1 site in 1 country212 target enrollmentStarted: August 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Market Research Survey
Study Overview
Brief Summary
The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 38 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must be females of Chinese descent and of legal age and no older than
- •OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.
Exclusion Criteria
- •Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •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 scar or neovascularization within the central 4 mm of the cornea.
- •Subjects who are aphakic or amblyopic.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who currently wear monovision, multifocal, or toric contact lenses.
Arms & Interventions
Prism I
Experimental
Bausch & Lomb daily disposable cosmetic tint contact lens
Intervention: Daily disposable cosmetic tint lens (Device)
Outcomes
Primary Outcomes
Market Research Survey
Time Frame: 1 week
Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.
Secondary Outcomes
- Lens Evaluation - Movement(Over all study visits through 1 week)
- Lens Evaluation - Centration(Over all study visits through 1 week)
- Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).(Over all study visits for 1 week)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Product Design Clinical Performance Study of sc2Wear Furosemide Combination ProductHeart FailureNCT02804282scPharmaceuticals, Inc.74
Withdrawn
Not Applicable
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.Diabetes Mellitus, Type 2NCT05129735Teatis, Inc
Recruiting
Phase 2
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line TherapyMetastatic Colorectal CancerNCT05962502Sun Yat-sen University54
Completed
Not Applicable
Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM PatientsNeoplasmsNeoplasms, Nerve TissueGlioblastoma MultiformeBrain TumorGlioblastomaGliomaNCT04446416NaviFUS Corporation6
Completed
Phase 1
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy SubjectsHepatic ImpairmentNCT02683577Ipsen24