One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers

NCT02081677 | Completed Results FDA Device

• 1 other identifier: CR-5146
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.

Conditions

Visual Correction

Outcome Measures

Primary Outcomes (21)

• Corneal Staining (Area)

  Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.

  Baseline and 4-Week Follow-up

• Corneal Staining (Depth)

  Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.

  Baseline and 4-Week Follow-up

• Corneal Staining (Type)

  Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.

  Baseline and 4-Week Follow-up

• Limbal Conjunctival Redness

  Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.

  Baseline and 2-Week Follow-up

• Bulbar Conjunctival Redness

  Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.

  Baseline and 2-Week Follow-up

• Visual Acuity (LogMAR)

  Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.

  4-Week Follow-up

• Lens Fitting Characteristics

  Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.

  Post Lens Fitting and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Burning/Stinging)

  The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Corneal Edema

  Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

  Baseline and 4-Week Follow-up

• Conjunctival Injection

  Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

  Baseline and 4-Week Follow-up

• Corneal Neovascularization

  Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

  Baseline and 4-Week Follow-up

• Corneal Staining

  Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

  Baseline and 4-Week Follow-up

• Tarsal Abnormalities

  Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.

  1-, 2- and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)

  The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Dryness)

  The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)

  The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Irritation/Discomfort)

  The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)

  The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Lens Awareness)

  The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Redness)

  The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

• Percentage of Reported Ocular Symptoms (Variable Vision)

  The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

  Baseline and 4-Week Follow-up

Study Arms (4)

etafilcon A

ACTIVE COMPARATOR

Marketed control soft contact lens

Device: ACUVUE 2

Prototype E1

EXPERIMENTAL

Investigational soft contact lens

Device: Prototype E1

Prototype E2

EXPERIMENTAL

Investigational soft contact lens

Device: Prototype E2

Prototype E3

EXPERIMENTAL

Investigational soft contact lens

Device: Prototype E3

Interventions

ACUVUE 2 DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

etafilcon A

Prototype E1 DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Also known as: Investigational soft contact lens

Prototype E1

Prototype E2 DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Also known as: Investigational soft contact lens

Prototype E2

Prototype E3 DEVICE

worn in a daily wear modality; lenses will be replaced after 2 weeks

Also known as: Investigational soft contact lens

Prototype E3

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be between 18 and 39 years of age.
• The subject must be able to read and understand English.
• The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
• The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
• The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
• The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
• The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
• The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
• The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
• The subject must require a visual correction in both eyes (no monofit or monovision allowed).
• The subject must 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, corneal scaring, infiltrates or abnormal opacities).

You may not qualify if:

• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
• Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
• No extended wear in the last 3 months.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
• Has had refractive surgery.
• Employee of VRF with direct involvement in the study or a family member of the clinic.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Chennai, Tamil Nadu, 600 006, India

Location

Results Point of Contact

• Title: Tawnya Wilson, Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

TWilson@ITS.JNJ.com

904-443-1834

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: February 6, 2014
• Primary Completion: June 25, 2014
• Study Completion: June 25, 2014
• Last Updated: June 19, 2018
• Results First Posted: August 17, 2017

Record last verified: 2017-07

Locations

IN (1)