Astigmatism
Conditions
Brief summary
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.
Detailed description
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
Interventions
DEVICESoft Toric Custom Made Contact lens
Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
DEVICESoft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
DEVICESpectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
\- Subjects will only be eligible for the study if: 1. They are of legal age between 18 and 40 years. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months). 5. They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes. 6. They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS. 7. They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range. 8. They can be fitted satisfactorily with both lens types. 9. They own an acceptable pair of spectacles. 10. They agree not to participate in other clinical research for the duration of this study.
Exclusion criteria
\- Subjects will not be eligible to take part in the study if: 1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They have had corneal refractive surgery. 5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 6. They are pregnant or breastfeeding. 7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 8. They have an amblyopic eye, in which case only dominant eye will be assessed for that subject. 9. They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes. 10. They have a history of severe allergic reaction or anaphylaxis. 11. They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline with low contrast VA | Visual acuity was assessed using logMAR for each intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Biomicroscopy Findings - Limbal Redness | Entrance (Prior to wear of study lens) | 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. |
| Slit Lamp Biomicroscopy Findings - Corneal Staining | Entrance (Prior to wear of study lens) | 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. |
| Slit Lamp Biomicroscopy Findings - Conjunctival Redness | Entrance (Prior to wear of study lens) | 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. |
| Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | Entrance (Prior to wear of study lens) | 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. |
| Slit Lamp Biomicroscopy Findings - Corneal Oedema | Entrance (Prior to wear of study lens) | 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. |
| Slit Lamp Biomicroscopy Findings - Conjunctival Staining | Entrance (Prior to wear of study lens) | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spherical Contact Lens, Spectacles, Toric Contact Lens Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes | 14 |
| Spherical Contact Lens, Spectacles, Toric Contact Lens Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes | 23 |
| Spherical Contact Lens, Toric Contact Lens, Spectacles Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes | 6 |
| Spherical Contact Lens, Toric Contact Lens, Spectacles Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes | 9 |
| Spectacles, Spherical Contact Lens, Toric Contact Lens Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes | 9 |
| Spectacles, Spherical Contact Lens, Toric Contact Lens Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes | 15 |
| Spectacles, Toric Contact Lens, Spherical Contact Lens Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes | 5 |
| Spectacles, Toric Contact Lens, Spherical Contact Lens Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes | 6 |
| Toric Contact Lens, Spherical Contact Lens, Spectacles Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes | 6 |
| Toric Contact Lens, Spherical Contact Lens, Spectacles Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes | 9 |
| Toric Contact Lens, Spectacles, Spherical Contact Lens Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes | 13 |
| Toric Contact Lens, Spectacles, Spherical Contact Lens Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes | 22 |
| Total | 137 |
Baseline characteristics
| Characteristic | Toric Contact Lens, Spectacles, Spherical Contact Lens | Total | Spherical Contact Lens, Spectacles, Toric Contact Lens | Spherical Contact Lens, Toric Contact Lens, Spectacles | Spectacles, Spherical Contact Lens, Toric Contact Lens | Spectacles, Toric Contact Lens, Spherical Contact Lens | Toric Contact Lens, Spherical Contact Lens, Spectacles |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 6.3 | 26.5 years STANDARD_DEVIATION 5.7 | 26.1 years STANDARD_DEVIATION 4.8 | 27.3 years STANDARD_DEVIATION 5.6 | 25.9 years STANDARD_DEVIATION 5 | 28.2 years STANDARD_DEVIATION 7.7 | 25.4 years STANDARD_DEVIATION 6.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — | — | — |
| Sex: Female, Male Female | 17 Eyes | 58 Eyes | 14 Eyes | 5 Eyes | 13 Eyes | 6 Eyes | 3 Eyes |
| Sex: Female, Male Male | 5 Eyes | 26 Eyes | 9 Eyes | 4 Eyes | 2 Eyes | 0 Eyes | 6 Eyes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 4 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
Primary
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: Baseline with low contrast VA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Visual Acuity | 0.2 logMAR | Standard Deviation 0.09 |
Primary
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: After 30 minutes of dispense (Low Contrast VA)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Visual Acuity | 0.28 logMAR | Standard Deviation 0.013 |
| Soft Toric Custom Made Contact Lenses | Visual Acuity | 0.24 logMAR | Standard Deviation 0.09 |
| Spectacle Correction | Visual Acuity | 0.21 logMAR | Standard Deviation 0.09 |
Primary
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: Baseline with High contrast VA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Visual Acuity | -0.07 logMAR | Standard Deviation 0.07 |
Primary
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: After 30 minutes of dispense (High Contrast VA)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Visual Acuity | -0.02 logMAR | Standard Deviation 0.11 |
| Soft Toric Custom Made Contact Lenses | Visual Acuity | -0.08 logMAR | Standard Deviation 0.07 |
| Spectacle Correction | Visual Acuity | -0.1 logMAR | Standard Deviation 0.06 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Conjunctival Redness | 1.0 units on a scale | Standard Deviation 0.3 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Conjunctival Redness | 1.0 units on a scale | Standard Deviation 0.3 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Conjunctival Staining | 0.6 units on a scale | Standard Deviation 0.5 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Conjunctival Staining | 0.4 units on a scale | Standard Deviation 0.4 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Corneal Oedema | 0.0 units on a scale | Standard Deviation 0 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Corneal Oedema | 0.0 units on a scale | Standard Deviation 0 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Corneal Staining | 0.3 units on a scale | Standard Deviation 0.5 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Corneal Staining | 0.2 units on a scale | Standard Deviation 0.5 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Limbal Redness | 0.9 units on a scale | Standard Deviation 0.3 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Limbal Redness | 0.9 units on a scale | Standard Deviation 0.3 |
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.
Time frame: Entrance (Prior to wear of study lens)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | 1.1 units on a scale | Standard Deviation 0.3 |
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.
Time frame: At Exit (After 30 minutes in each of three interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Participants | Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis | 1.1 units on a scale | Standard Deviation 0.3 |