Astigmatism
Conditions
Brief summary
This study aimed to compare the clinical performance of two daily disposable toric contact lenses.
Detailed description
This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.
Interventions
DEVICELens A (delefilcon A)
Daily disposable for one week
DEVICELens B (stenfilcon A)
Daily disposable for one week
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are at least 18 years old and have the capacity to volunteer. 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 currently wear soft contact lenses or have done so in the past two years. 5. They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive). 6. They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive). 7. They can be satisfactorily fitted with the study lens types. 8. At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. 9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). 10. They own a wearable pair of spectacles. 11. They agree not to participate in other clinical research while enrolled on this study.
Exclusion criteria
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 are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breastfeeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. They have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 10. They are currently wearing one of the study contact lenses. 11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Handling Rating on Lens Removal | One week | Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lens Fit at Follow-up | One Week | Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered Acceptable. For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum. |
| Biomicroscopy Score at Follow-up | One week | Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 55 participants were dispensed study lenses, and 54 completed the study. Five participants discontinued the study prior to dispensing and were therefore not included in either the enrollment count or data analysis population. Nine participants were ineligible.
Pre-assignment details
Five participants were initially ineligible, but were re-enrolled following a protocol amendment that expanded the age range and allowed the use of an increased range of lens axes for Lens A.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants who were dispensed lenses and successfully completed the study. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 34.6 years STANDARD_DEVIATION 13.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 5 / 54 | 1 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Subjective Handling Rating on Lens Removal
Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.
Time frame: One week
Population: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit.~Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. Another participant's subjective scores and symptoms were not collected at the correct study visit in error, and their data was subsequently excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Subjective Handling Rating on Lens Removal | 85.5 units on a scale | Standard Deviation 17.7 |
| Lens B | Subjective Handling Rating on Lens Removal | 83.3 units on a scale | Standard Deviation 20.1 |
Secondary
Biomicroscopy Score at Follow-up
Slit lamp biomicroscopy was used to assign grades to various biomicroscopic signs, as assessed by investigator, using Efron Grading Scales scored to the nearest 0.1 unit. Grading ranged from 0-4, where 0=None and 4=Severe.
Time frame: One week
Population: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit.~Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit. For parameter 'mucin balls', data from an additional participant was not collected in error.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lens A | Biomicroscopy Score at Follow-up | Blepharitis | 0.06 score on a scale | Standard Deviation 0.16 |
| Lens A | Biomicroscopy Score at Follow-up | Corneal vascularisation | 0.05 score on a scale | Standard Deviation 0.15 |
| Lens A | Biomicroscopy Score at Follow-up | Mucin balls | 0.00 score on a scale | Standard Deviation 0 |
| Lens A | Biomicroscopy Score at Follow-up | Corneal oedema | 0.00 score on a scale | Standard Deviation 0 |
| Lens A | Biomicroscopy Score at Follow-up | Limbal hyperaemia | 0.63 score on a scale | Standard Deviation 0.41 |
| Lens A | Biomicroscopy Score at Follow-up | Corneal staining | 0.23 score on a scale | Standard Deviation 0.37 |
| Lens A | Biomicroscopy Score at Follow-up | Papillary conjunctivitis | 0.90 score on a scale | Standard Deviation 0.4 |
| Lens A | Biomicroscopy Score at Follow-up | Conjunctival staining | 0.41 score on a scale | Standard Deviation 0.44 |
| Lens A | Biomicroscopy Score at Follow-up | Meibomian gland dysfunction | 0.16 score on a scale | Standard Deviation 0.32 |
| Lens A | Biomicroscopy Score at Follow-up | Conjunctival hyperaemia | 0.82 score on a scale | Standard Deviation 0.32 |
| Lens B | Biomicroscopy Score at Follow-up | Mucin balls | 0.10 score on a scale | Standard Deviation 0.69 |
| Lens B | Biomicroscopy Score at Follow-up | Papillary conjunctivitis | 0.90 score on a scale | Standard Deviation 0.43 |
| Lens B | Biomicroscopy Score at Follow-up | Blepharitis | 0.06 score on a scale | Standard Deviation 0.15 |
| Lens B | Biomicroscopy Score at Follow-up | Meibomian gland dysfunction | 0.09 score on a scale | Standard Deviation 0.18 |
| Lens B | Biomicroscopy Score at Follow-up | Limbal hyperaemia | 0.64 score on a scale | Standard Deviation 0.4 |
| Lens B | Biomicroscopy Score at Follow-up | Conjunctival hyperaemia | 0.76 score on a scale | Standard Deviation 0.31 |
| Lens B | Biomicroscopy Score at Follow-up | Corneal vascularisation | 0.03 score on a scale | Standard Deviation 0.09 |
| Lens B | Biomicroscopy Score at Follow-up | Corneal oedema | 0.00 score on a scale | Standard Deviation 0 |
| Lens B | Biomicroscopy Score at Follow-up | Corneal staining | 0.20 score on a scale | Standard Deviation 0.32 |
| Lens B | Biomicroscopy Score at Follow-up | Conjunctival staining | 0.53 score on a scale | Standard Deviation 0.49 |
Secondary
Overall Lens Fit at Follow-up
Lens fit was reported as either optimum, acceptable, or unacceptable. To determine this, lens fit parameters (horizontal centration, vertical centration, corneal coverage, and lens movement) were measured on a 5-point scale (-2 to +2), where -2=Extremely nasal, 0=Optimum, and +2=Extremely temporal. Scores between -1 and +1 were considered Acceptable. For overall lens fit to be 'acceptable', no parameters could be extreme. For a score to be 'optimum', all parameters needed to be optimum.
Time frame: One Week
Population: Lens A: all data for one participant was discounted, as the follow-up visit took place significantly outside the date range for this visit.~Lens B: all data for a different participant was discounted, as the follow-up visit took place significantly outside the date range for this visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lens A | Overall Lens Fit at Follow-up | Optimum | 23 Participants |
| Lens A | Overall Lens Fit at Follow-up | Acceptable | 53 Participants |
| Lens A | Overall Lens Fit at Follow-up | Unacceptable | 0 Participants |
| Lens B | Overall Lens Fit at Follow-up | Unacceptable | 0 Participants |
| Lens B | Overall Lens Fit at Follow-up | Optimum | 20 Participants |
| Lens B | Overall Lens Fit at Follow-up | Acceptable | 53 Participants |