Myopia Clinical Trial
Official title:
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
NCT number | NCT01583868 |
Other study ID # | 755E |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | July 2012 |
Verified date | September 2020 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
Status | Completed |
Enrollment | 216 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. - Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. - Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. - Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye. - Must agree to wear the study lenses on a daily wear basis for the duration of the study. - Must be willing to use a lens care system on a regular basis. - If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period. Exclusion Criteria: - Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. - Have an active ocular disease, any corneal infiltrative response or are using any ocular medications. - Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. - Any scar or neovascularization within the central 4mm of the cornea. - Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible. - Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. - Anisometropia (spherical equivalent) of greater than 2.00 D. - Any systemic disease affecting ocular health. - Using any systemic or topical medications that will affect ocular physiology or lens performance. - Aphakic. - Amblyopic. - Allergic to any component in the study products. - Have had any corneal surgery (ie, refractive surgery). - Currently wear monovision correction, multifocal, or toric contact lenses. - Ocular astigmatism greater than 1.00 D in either eye. |
Country | Name | City | State |
---|---|---|---|
United States | Bausch & Lomb Incorporated | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up | |
Secondary | Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression. | At 1 Week follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04923841 -
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine
|
N/A | |
Active, not recruiting |
NCT04080128 -
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
|
N/A | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Completed |
NCT04604405 -
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
|
N/A | |
Recruiting |
NCT05594719 -
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
|
N/A | |
Completed |
NCT05594732 -
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
|
N/A | |
Completed |
NCT04492397 -
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
|
N/A | |
Completed |
NCT04536571 -
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
|
N/A | |
Completed |
NCT06046209 -
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
|
N/A | |
Recruiting |
NCT06344572 -
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
|
Phase 3 | |
Recruiting |
NCT05611294 -
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
|
N/A | |
Completed |
NCT05656885 -
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
|
N/A | |
Active, not recruiting |
NCT05534022 -
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.
|
N/A | |
Completed |
NCT03934788 -
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT03701516 -
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
|
N/A | |
Completed |
NCT05538754 -
Post-Market Evaluation of the EVO ICL
|
N/A | |
Completed |
NCT03139201 -
Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT02555722 -
Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
|
N/A | |
Not yet recruiting |
NCT06009458 -
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
|
N/A | |
Recruiting |
NCT05548478 -
Corneal Endothelial Cell Injury Induced by Mitomycin-C
|
N/A |