An interventional study of lotrafilcon B and etafilcon A in Presbyopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 20 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 371 is above the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
Device: lotrafilcon B · Device: etafilcon A
Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.
Device: lotrafilcon B · Device: etafilcon A
Soft contact lens to be worn as daily wear, monthly replacement modality.
Also known as: AirOptix Aqua Multifocal
Soft contact lens to be worn as daily wear, daily disposable modality.
Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time frame: 8 -12 days post wear
Distance Binocular Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Time frame: 8- 12 Days post wear
Intermediate Binocular Visual Acuity (LogMAR)
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Near Binocular Visual Acuity (LogMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time frame: 8-12 days post wear
Corneal Staining
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8 - 12 Days post wear
Bulbar Conjunctival Injection
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Limbal Conjunctival Injection
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time frame: 8- 12 Days post wear
Contact Lens Fitting
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Time frame: 8- 12 Days post wear
| Milestone | Etafilcon A / Lotrafilcon B | Lotrafilcon B/ Etafilcon A |
|---|---|---|
| Started | 163 | 159 |
| Completed | 159 | 144 |
| Not completed | 4 | 15 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Protocol violation | 2 | 4 |
| Withdrew: Withdrawal by subject | 0 | 4 |
| Withdrew: Test article no longer available | 1 | 5 |
| Withdrew: Unsatisfactory visual response | 0 | 1 |
| Milestone | Etafilcon A / Lotrafilcon B | Lotrafilcon B/ Etafilcon A |
|---|---|---|
| Started | 159 | 144 |
| Completed | 156 | 141 |
| Not completed | 3 | 3 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lens discomfort | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Test article no longer available | 0 | 1 |
CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is 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. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
| units on a scale | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=94, N=94 | 51.15 ± 21.647 | 54.28 ± 20.749 |
| Myopes, N=181, N=181 | 53.55 ± 18.644 | 51.84 ± 19.319 |
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
| LogMAR | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=94, N=94 | -0.069 ± 0.0908 | -0.066 ± 0.0982 |
| Myopes, N=180, N=181 | -0.100 ± 0.0991 | -0.093 ± 0.0981 |
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
| LogMAR | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=94, N=94 | -0.061 ± 0.0829 | -0.050 ± 0.0897 |
| Myopes, N=180, N=181 | -0.081 ± 0.0803 | -0.063 ± 0.0894 |
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
| LogMAR | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=94, N=94 | 0.050 ± 0.0970 | 0.074 ± 0.1035 |
| Myopes, N=180, N=181 | 0.034 ± 0.1039 | 0.049 ± 0.1176 |
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
| percentage of Subject Eyes | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=188, N=188 | 0.0 | 0.0 |
| Myopes, N=362, N=362 | 0.0 | 0.0 |
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
| Percentage of Subject Eyes | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=188, N=188 | 0.0 | 0.0 |
| Myopes, N=362 , N=362 | 0.0 | 0.0 |
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
| Percentage of Subject Eyes | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=188, N=188 | 0.0 | 0.0 |
| Myopes, N=362, N=362 | 0.0 | 0.0 |
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
| Percentage of Subject Eyes | Etafilcon A | Lotrafilcon B |
|---|---|---|
| Hyperopes, N=188, N=188 | 100 | 100 |
| Myopes, N=362, N=362 | 99.5 | 100 |
Collected over Approximately 8-12 days per intervention.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etafilcon A | — | 0/307 (0%) | 0/307 (0%) |
| Lotrafilcon B | — | 0/318 (0%) | 0/318 (0%) |
The analysis population consists of subjects that were dispensed a study lens.
| Age, Continuous(years) | Etafilcon A / Lotrafilcon B | Lotrafilcon B / Etafilcon A | Total |
|---|---|---|---|
| Hyperopes, N=59, N=53, N=112 | 52.3 ± 6.59 | 51.9 ± 7.04 | 52.1 ± 6.78 |
| Myopes, N=104, N=106, N=210 | 49.3 ± 6.10 | 49.5 ± 5.77 | 49.4 ± 5.92 |
| Sex: Female, Male(Participants) | Etafilcon A / Lotrafilcon B | Lotrafilcon B / Etafilcon A | Total |
|---|---|---|---|
| Female | 128 | 120 | 248 |
| Male | 35 | 39 | 74 |
| Race/Ethnicity, Customized(participants) | Etafilcon A / Lotrafilcon B | Lotrafilcon B / Etafilcon A | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 3 | 4 |
| Black or African American | 15 | 10 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 147 | 144 | 291 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(participants) | Etafilcon A / Lotrafilcon B | Lotrafilcon B / Etafilcon A | Total |
|---|---|---|---|
| United States | 163 | 159 | 322 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.