Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johnson & Johnson Vision Care, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.
This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test followed by control | Other | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit. |
|
| Control followed by test | Other | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Daily Disposable Soft Contact Lenses | Device | Worn daily for 7 +/- 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Symptom Improvement | The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms). | Baseline and after 1 week of wearing each lens. |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Preference | Based on two alternative forced choice method | 2 weeks |
| Lag of Accommodation in Study Lenses | Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Danielle Iacono, OD | SUNY Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY College of Optometry | New York | New York | 10036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1. | ||
| Background | Rueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015. | ||
| Background | Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10. | ||
| 15315652 | Background | Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90. doi: 10.1111/j.1475-1313.2004.00202.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test 1 Week, Followed by Control 1 Week, no Washout | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days |
| FG001 | Control 1 Week, Followed by Test 1 Week, no Washout | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test Followed by Control | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Symptom Improvement | The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms). | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. One week data for the primary outcome was available for 22 subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after 1 week of wearing each lens. |
|
Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multifocal Contact Lenses | Adverse Events while wearing Multifocal Contact Lenses |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperemia | Eye disorders | Non-systematic Assessment | Occurred after lens removal |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Iacono, OD | SUNY College of Optometry Clinical Vision Research Center | 212-938-5936 | diacono@sunyopt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2017 | Jul 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2018 | Aug 7, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001248 | Asthenopia |
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Daily Disposable Soft Contact Lenses | Device | Worn daily for 7 +/- 2 days |
|
| 1 week |
| Convergence Insufficiency Symptom Survey (CISS) | Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60. | 1 week |
| Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms). | 1 week |
| Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | Measured via Modified Thorington | 1 week |
| 22960615 | Background | Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 2012 Oct;89(10):1435-42. doi: 10.1097/OPX.0b013e318269c90d. |
| 11913842 | Background | Jaschinski W. The proximity-fixation-disparity curve and the preferred viewing distance at a visual display as an indicator of near vision fatigue. Optom Vis Sci. 2002 Mar;79(3):158-69. doi: 10.1097/00006324-200203000-00010. |
| 16699438 | Background | Richdale K, Mitchell GL, Zadnik K. Comparison of multifocal and monovision soft contact lens corrections in patients with low-astigmatic presbyopia. Optom Vis Sci. 2006 May;83(5):266-73. doi: 10.1097/01.opx.0000216098.62165.34. |
| 26228543 | Background | Fedtke C, Bakaraju RC, Ehrmann K, Chung J, Thomas V, Holden BA. Visual performance of single vision and multifocal contact lenses in non-presbyopic myopic eyes. Cont Lens Anterior Eye. 2016 Feb;39(1):38-46. doi: 10.1016/j.clae.2015.07.005. Epub 2015 Jul 27. |
| Background | Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34. |
| Background | Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13. |
| 17700327 | Background | Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546. |
| BG001 | Control Followed by Test | Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit. Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Arm: Single Vision Spherical Contact Lenses | Symptoms after one week of wearing single vision soft spherical contact lenses. |
| OG002 | Baseline Symptoms | Symptoms at visit one in habitual contact lenses |
|
|
|
| Secondary | Lens Preference | Based on two alternative forced choice method | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Lag of Accommodation in Study Lenses | Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag. | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects. | Posted | Mean | Standard Deviation | Diopters | 1 week |
|
|
|
|
| Secondary | Convergence Insufficiency Symptom Survey (CISS) | Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60. | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects. | Posted | Mean | Standard Deviation | score on a scale | 1 week |
|
|
|
|
| Secondary | Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms). | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects. | Posted | Mean | Standard Deviation | score on a scale | 1 week |
|
|
|
|
| Secondary | Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | Measured via Modified Thorington | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects. | Posted | Mean | Standard Deviation | Prism Diopters of Exophoria | 1 week |
|
|
|
|
| Post-Hoc | Participants Stratified by Subjects' Near Phoria With Single Vision Lenses | Phoria at near as measured through the single vision spherical contact lenses | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Post-Hoc | Phoria and Lens Preference | Subjects' phoria at near with single vision lenses was classified as esophoric or exophoric. Lens preference was compared (multifocal vs single vision lenses) between the subjects who were esophoric at near vs the subjects who were exophoric/orthophoric at near. | Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Of the 22 completed subjects, 5 had an esophoria at near. 17 were exophoric or orthophoric at near. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Single Vision Contact Lenses | Adverse Events while wearing Single Vision Contact Lenses | 0 | 23 | 0 | 23 | 1 | 23 |
|
| Cold Like Symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Subcojnunctival Hemorrhage | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Lag at Distance |
|