--- title: Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses nct_id: NCT01244516 overall_status: COMPLETED phase: NA sponsor: Johnson & Johnson Vision Care, Inc. study_type: INTERVENTIONAL primary_condition: Myopia countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01244516.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01244516" ct_last_update_post_date: 2018-06-19 last_seen_at: "2026-05-12T06:40:19.214Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses **NCT ID:** [NCT01244516](https://clinicaltrials.gov/study/NCT01244516) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 540 - **Lead Sponsor:** Johnson & Johnson Vision Care, Inc. - **Conditions:** Myopia - **Start Date:** 2010-09-01 - **Completion Date:** 2010-11-01 - **CT.gov Last Update:** 2018-06-19 ## Brief Summary The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 39 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Be no less than 18 and no more than 39 years of age. * Sign Written Informed Consent and investigator to record this on Case Report Form. * Be willing and able to adhere to the instructions set out in the protocol. * Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month. * No extended wear in the last 3 months. * Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters. * Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes. * Achieve visual acuity of 6/9 (20/30) or better in each eye. * Require a visual correction in both eyes (no monovision allowed). * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease. Exclusion Criteria: * Requires concurrent ocular medication. * Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. * Clinically significant corneal staining * Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters). * Has had refractive surgery. * Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study. * Abnormal lacrimal secretions. * Pre-existing ocular irritation that would preclude contact lens fitting. * Keratoconus or other corneal irregularity. * Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks. * Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * Diabetic. * Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\]. * History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration). * Pregnancy, lactating or planning a pregnancy at the time of enrollment. * Participation in any concurrent clinical trial or in last 30 days ``` ## Arms - **galyfilcon A** (OTHER) — Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. - **lotrafilcon B** (OTHER) — Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. - **comfilcon A** (OTHER) — Subjects that were randomized to wear comfilcon A lens throughout the course of the study. ## Interventions - **galyfilcon A, BC 8.30** (DEVICE) — galyfilcon A, BC 8.30 soft contact lens - **lotrafilcon B, BC 8.60** (DEVICE) — lotrafilcon B, BC 8.60 soft contact lens - **comfilcon A, BC 8.60** (DEVICE) — comfilcon A, BC 8.60 soft contact lens ## Primary Outcomes - **Overall Subjective Comfort** _(time frame: after 2 weeks of contact lens wear)_ — Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. - **Corneal Staining** _(time frame: after 2 weeks of contact lens wear)_ — Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated. ## Secondary Outcomes - **Overall Subjective Lens Handling** _(time frame: after 2 weeks of contact lens wear)_ ## Locations (35) - Brea, California, United States - Campbell, California, United States - Cupertino, California, United States - Mission Viejo, California, United States - Colorado Springs, Colorado, United States - Bridgeport, Connecticut, United States - Aventura, Florida, United States - Jacksonville, Florida, United States - Tallahassee, Florida, United States - Tampa, Florida, United States - Winter Park, Florida, United States - Roswell, Georgia, United States - Bloomington, Illinois, United States - Mishawaka, Indiana, United States - Pittsburg, Kansas, United States - Boston, Massachusetts, United States - Independence, Missouri, United States - Raytown, Missouri, United States - Closter, New Jersey, United States - New York, New York, United States - Raleigh, North Carolina, United States - North Olmsted, Ohio, United States - Powell, Ohio, United States - Kittanning, Pennsylvania, United States - Warwick, Rhode Island, United States - Chamberlain, South Dakota, United States - Bartlett, Tennessee, United States - Brentwood, Tennessee, United States - Memphis, Tennessee, United States - Tyler, Texas, United States - Tyler, Texas, United States - Salt Lake City, Utah, United States - Burlington, Vermont, United States - Salem, Virginia, United States - Virginia Beach, Virginia, United States ## Recent Field Changes (last 30 days) - `locations.|campbell|california|united states` — added _(2026-05-12)_ - `locations.|cupertino|california|united states` — added _(2026-05-12)_ - `locations.|mission viejo|california|united states` — added _(2026-05-12)_ - `locations.|colorado springs|colorado|united states` — added _(2026-05-12)_ - `locations.|bridgeport|connecticut|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|brea|california|united states` — added _(2026-05-12)_ - `locations.|aventura|florida|united states` — added _(2026-05-12)_ - `locations.|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.|tallahassee|florida|united states` — added _(2026-05-12)_ - `locations.|tampa|florida|united states` — added _(2026-05-12)_ - `locations.|winter park|florida|united states` — added _(2026-05-12)_ - `locations.|roswell|georgia|united states` — added _(2026-05-12)_ - `locations.|bloomington|illinois|united states` — added _(2026-05-12)_ - `locations.|mishawaka|indiana|united states` — added _(2026-05-12)_ - `locations.|pittsburg|kansas|united states` — added _(2026-05-12)_ - `locations.|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.|independence|missouri|united states` — added _(2026-05-12)_ - `locations.|raytown|missouri|united states` — added _(2026-05-12)_ - `locations.|closter|new jersey|united states` — added _(2026-05-12)_ - `locations.|new york|new york|united states` — added _(2026-05-12)_ - `locations.|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.|north olmsted|ohio|united states` — added _(2026-05-12)_ - `locations.|powell|ohio|united states` — added _(2026-05-12)_ - `locations.|kittanning|pennsylvania|united states` — added _(2026-05-12)_ - `locations.|warwick|rhode island|united states` — added _(2026-05-12)_ - `locations.|chamberlain|south dakota|united states` — added _(2026-05-12)_ - `locations.|bartlett|tennessee|united states` — added _(2026-05-12)_ - `locations.|brentwood|tennessee|united states` — added _(2026-05-12)_ - `locations.|memphis|tennessee|united states` — added _(2026-05-12)_ - `locations.|tyler|texas|united states` — added _(2026-05-12)_ - `locations.|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.|burlington|vermont|united states` — added _(2026-05-12)_ - `locations.|salem|virginia|united states` — added _(2026-05-12)_ - `locations.|virginia beach|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01244516.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01244516* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*