Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

Conditions

Astigmatism

Keywords

astigmatism, visual acuity, orientation, contact lenses

Brief summary

The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Detailed description

Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Related papers

No related papers found yet.

Interventions

DEVICEsenofilcon A

toric contact lens

DEVICEbalafilcon A

toric contact lens

DEVICEomafilcon A

toric contact lens

DEVICElotrafilcon B

toric contact lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

No

Inclusion criteria

1. They are aged between 18-39 years. 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They can attain at least 6/9 in each eye with their spectacle refraction. 5. They have successfully worn contact lenses within six months of starting the study. 6. They can be fitted with toric soft contact lenses to match the available power range.

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 lactating. 8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity After Infero-temporal Version Movement.	10 minutes after insertion	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Infero-nasal Version Movement.	10 minutes after lens insertion	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-temporal Version Movement	10 minutes after lens insertion	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-nasal Version Movement.	10 minutes after lens insertion	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Total Study Population	40
Total	40

Baseline characteristics

Characteristic	Total Study Population
Age, Continuous	28.3 years STANDARD_DEVIATION 7.9
Region of Enrollment United Kingdom	40 participants
Sex: Female, Male Female	28 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 40	0 / 40	0 / 40	0 / 40
serious Total, serious adverse events	0 / 40	0 / 40	0 / 40	0 / 40

Outcome results

Primary

Visual Acuity After Infero-nasal Version Movement.

logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

Time frame: 10 minutes after lens insertion

Arm	Measure	Value (MEAN)	Dispersion
Lotrafilcon B	Visual Acuity After Infero-nasal Version Movement.	0.12 LogMAR units	Standard Deviation 0.16
Senofilcon A	Visual Acuity After Infero-nasal Version Movement.	0.11 LogMAR units	Standard Deviation 0.16
Omafilcon A	Visual Acuity After Infero-nasal Version Movement.	0.14 LogMAR units	Standard Deviation 0.17
Balafilcon A	Visual Acuity After Infero-nasal Version Movement.	0.15 LogMAR units	Standard Deviation 0.2