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Completed

NCT Number: NCT05020990

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cameron Optometry, Edinburgh, Edinburg, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They are at least 18 years old and have the capacity to volunteer.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They currently wear soft contact lenses or have done so in the past two years.
  • They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
  • They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
  • They can be satisfactorily fitted with the study lens types.
  • 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.
  • They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
  • They own a wearable pair of spectacles.
  • They agree not to participate in other clinical research while enrolled on this study.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder, which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breastfeeding.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • 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.
  • They are currently wearing one of the study contact lenses.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

Lens A (delefilcon A)

Device

Daily disposable for one week

Lens B (stenfilcon A)

Device

Daily disposable for one week

Primary outcomes

  1. Subjective Handling Rating on Lens Removal

    Time frame: One week

    Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.

Secondary outcomes

  1. Overall Lens Fit at Follow-up

    Time frame: 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.

  2. Biomicroscopy Score at Follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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