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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
B&L RD2135-01 lens C
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
B&L RD2135-01 lens D
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
PureVision2
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Air Optix Aqua
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.

Locations

Country Name City State
United States Bausch & Lomb Incorporated Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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
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