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

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ClinicalTrials.gov Identifier: NCT02081677
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : August 17, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Visual Correction Device: ACUVUE 2 Device: Prototype E1 Device: Prototype E2 Device: Prototype E3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One Month Daily Wear Clinical Evaluation of Three Prototype Soft Contact Lenses in a Population of Habitual and Neophyte Contact Lens Wearers
Actual Study Start Date : February 6, 2014
Actual Primary Completion Date : June 25, 2014
Actual Study Completion Date : June 25, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: etafilcon A
Marketed control soft contact lens
Device: ACUVUE 2
worn in a daily wear modality; lenses will be replaced after 2 weeks

Experimental: Prototype E1
Investigational soft contact lens
Device: Prototype E1
worn in a daily wear modality; lenses will be replaced after 2 weeks
Other Name: Investigational soft contact lens

Experimental: Prototype E2
Investigational soft contact lens
Device: Prototype E2
worn in a daily wear modality; lenses will be replaced after 2 weeks
Other Name: Investigational soft contact lens

Experimental: Prototype E3
Investigational soft contact lens
Device: Prototype E3
worn in a daily wear modality; lenses will be replaced after 2 weeks
Other Name: Investigational soft contact lens




Primary Outcome Measures :
  1. Corneal Staining (Area) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  2. Corneal Staining (Depth) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  3. Corneal Staining (Type) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  4. Limbal Conjunctival Redness [ Time Frame: Baseline and 2-Week Follow-up ]
    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.

  5. Bulbar Conjunctival Redness [ Time Frame: Baseline and 2-Week Follow-up ]
    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.

  6. Visual Acuity (LogMAR) [ Time Frame: 4-Week Follow-up ]
    Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.

  7. Lens Fitting Characteristics [ Time Frame: Post Lens Fitting and 4-Week Follow-up ]
    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.

  8. Percentage of Reported Ocular Symptoms (Burning/Stinging) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  9. Corneal Edema [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  10. Conjunctival Injection [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  11. Corneal Neovascularization [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  12. Corneal Staining [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  13. Tarsal Abnormalities [ Time Frame: 1-, 2- and 4-Week Follow-up ]
    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.

  14. Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  15. Percentage of Reported Ocular Symptoms (Dryness) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  16. Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  17. Percentage of Reported Ocular Symptoms (Irritation/Discomfort) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  18. Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  19. Percentage of Reported Ocular Symptoms (Lens Awareness) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  20. Percentage of Reported Ocular Symptoms (Redness) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.

  21. Percentage of Reported Ocular Symptoms (Variable Vision) [ Time Frame: Baseline and 4-Week Follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must be between 18 and 39 years of age.
  2. The subject must be able to read and understand English.
  3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
  5. 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).
  6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
  7. 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.
  8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
  9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
  10. The subject must require a visual correction in both eyes (no monofit or monovision allowed).
  11. 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).
    • No other active ocular diseases.

Exclusion Criteria:

  1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  2. Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  3. 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.
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
  6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
  7. No extended wear in the last 3 months.
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
  10. Has had refractive surgery.
  11. Employee of VRF with direct involvement in the study or a family member of the clinic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081677


Locations
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India
Chennai, Tamil Nadu, India, 600 006
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02081677     History of Changes
Other Study ID Numbers: CR-5146
First Posted: March 7, 2014    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: June 19, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes