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The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft Toric Custom Made contact lenses | Experimental | Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched. |
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| Soft Spherical Contact Lenses | Active Comparator | Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched |
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| Spectacle Correction | Active Comparator | Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Toric Custom Made Contact lens | Device | Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Baseline with low contrast VA |
| Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | After 30 minutes of dispense (Low Contrast VA) |
| Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Baseline with High contrast VA |
| Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | After 30 minutes of dispense (High Contrast VA) |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Biomicroscopy Findings - Conjunctival Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
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Inclusion Criteria:
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Subjects will only be eligible for the study if:
Exclusion Criteria:
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Subjects will not be eligible to take part in the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Read | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41579512 | Derived | Read M, Morgan P, Maldonado-Codina C, Orsborn G, Vega J, Navascues-Cornago M. Evaluating the visual benefits of toric soft contact lenses using a novel pupil-controlled vision testing system. Cont Lens Anterior Eye. 2025 Apr;49(2):102604. doi: 10.1016/j.clae.2025.102604. Epub 2026 Jan 23. |
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59 participants were screened for eligibility. Two participants did not meet the inclusion criteria and therefore were not included in the randomization. Each of the 3 interventions were subdivided into 7 cylinder groups based on required astigmatism range. Of the remaining 57 participants, 4 participants were assigned to cylinder groups which were already full and thus they did not receive any of the interventions. The remaining 53 participants completed the study using the three interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spherical Contact Lens, Spectacle, Toric Contact Lens | Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes |
| FG001 | Spherical Contact Lens, Toric Contact Lens, Spectacle | Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes |
| FG002 | Spectacle, Spherical Contact Lens, Toric Contact Lens | Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes |
| FG003 | Spectacles, Toric Contact Lens, Spherical Contact Lens | Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes |
| FG004 | Toric Contact Lens, Spherical Contact Lens, Spectacles | Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes |
| FG005 | Toric Contact Lens, Spectacles, Spherical Contact Lens | Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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There are six reporting groups for each of the randomization sequences of three study interventions. Here, we are not considering participants as some of the participants had only one eye examined and some of the participants had two eye examined. Therefore, we take number of eyes into consideration for better understanding and accuracy.
| ID | Title | Description |
|---|---|---|
| BG000 | Spherical Contact Lens, Spectacles, Toric Contact Lens | Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes |
| BG001 | Spherical Contact Lens, Toric Contact Lens, Spectacles |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Posted | Mean | Standard Deviation | logMAR | Baseline with low contrast VA | Eyes | Eyes |
|
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The data was collected in the time frame of 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | It is not possible to report the adverse Events per intervention as the measurements were taken prior to the first intervention and the following third intervention. Thus, the Adverse Events reporting have been combined. The eye twitch and migraine occurred after wearing all three interventions (Spectacles, Spherical Contact Lens and Toric Contact Lens) and thus these data cannot be subdivided. For the corneal scar and asymptomatic CIE these were observed on study but following wear of their habitual contact lenses and occurred prior to wear of the study interventions and thus these data cannot be further subdivided. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Scar | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, MSc, FAAO | Coopervision | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2020 | Jun 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Soft Spherical Contact Lenses | Device | Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched. |
|
| Spectacle Correction | Device | Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched. |
|
| Slit Lamp Biomicroscopy Findings - Conjunctival Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| Slit Lamp Biomicroscopy Findings - Limbal Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
| Slit Lamp Biomicroscopy Findings - Limbal Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| Slit Lamp Biomicroscopy Findings - Corneal Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
| Slit Lamp Biomicroscopy Findings - Corneal Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| Slit Lamp Biomicroscopy Findings - Conjunctival Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
| Slit Lamp Biomicroscopy Findings - Conjunctival Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
| Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| Slit Lamp Biomicroscopy Findings - Corneal Oedema | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Entrance (Prior to wear of study lens) |
| Slit Lamp Biomicroscopy Findings - Corneal Oedema | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | At Exit (After 30 minutes in each of three interventions) |
| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes
| BG002 | Spectacles, Spherical Contact Lens, Toric Contact Lens | Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes |
| BG003 | Spectacles, Toric Contact Lens, Spherical Contact Lens | Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes |
| BG004 | Toric Contact Lens, Spherical Contact Lens, Spectacles | Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes |
| BG005 | Toric Contact Lens, Spectacles, Spherical Contact Lens | Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes |
| BG006 | Total | Total of all reporting groups |
| Eyes |
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| years |
| Eyes |
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| Sex: Female, Male | Count of Units | Eyes | Eyes |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Eyes |
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| Primary | Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Posted | Mean | Standard Deviation | logMAR | After 30 minutes of dispense (Low Contrast VA) | Eyes | Eyes |
|
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| Primary | Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Posted | Mean | Standard Deviation | logMAR | Baseline with High contrast VA | Eyes | Eyes |
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| Primary | Visual Acuity | Visual acuity was assessed using logMAR for each intervention. | Posted | Mean | Standard Deviation | logMAR | After 30 minutes of dispense (High Contrast VA) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Conjunctival Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Conjunctival Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Limbal Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Limbal Redness | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Corneal Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Corneal Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Conjunctival Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Conjunctival Staining | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Corneal Oedema | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens. | Posted | Mean | Standard Deviation | units on a scale | Entrance (Prior to wear of study lens) | Eyes | Eyes |
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| Secondary | Slit Lamp Biomicroscopy Findings - Corneal Oedema | Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear. | Posted | Mean | Standard Deviation | units on a scale | At Exit (After 30 minutes in each of three interventions) | Eyes | Eyes |
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| 0 |
| 57 |
| 0 |
| 57 |
| 4 |
| 57 |
| asymptomatic corneal infiltrate event | Eye disorders | Systematic Assessment |
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| Twitching in the eye | Eye disorders | Systematic Assessment |
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| Migraine | General disorders | Systematic Assessment |
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| Male |
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