Clinical trial NCT05020990: The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Official title: The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective Handling Rating on Lens Removal
timeFrame: One week
Secondary outcomes:
measure: Overall Lens Fit at Follow-up
timeFrame: One Week
measure: Biomicroscopy Score at Follow-up
timeFrame: One week
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Cameron Optometry
state: Edinburg
city: Oakwood
country: United Kingdom
facility: Simon Falk Eyecare
state: Leeds
city: Heckmondwike
country: United Kingdom
facility: Phipps Opticians
Study officials:
affiliation: Eurolens Research
name: Philip Morgan
role: PRINCIPAL_INVESTIGATOR
References: