The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05020990
Collaborator
(none)
45
3
2
7
15
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Lens A (Test)
  • Device: Lens B (control)
N/A

Detailed Description

This will be a multi-centre, randomised, open-label, crossover, bilateral study, controlled by cross-comparison. Up to 55 subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear.

Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A (Test)

Subjects will be randomized to wear Lens A (Test) toric lens for one week.

Device: Lens A (Test)
Test toric lens

Device: Lens B (control)
Control toric lens

Active Comparator: Lens B (Control)

Subjects will be randomized to wear Lens B (control) toric lens for one week.

Device: Lens A (Test)
Test toric lens

Device: Lens B (control)
Control toric lens

Outcome Measures

Primary Outcome Measures

  1. Subjective handling ratings on lens removal [One week.]

    Subjective handling ratings on lens removal will be measured on a scale of 0-100 (0- Unmanageable, 20- Very poor , 40 - Poor, 60- Good, 80- Very good, 100- Excellent unsuccessful removal, 40 -

Secondary Outcome Measures

  1. Lens Fit - Horizontal Centration [One Week]

    Lens Fit - Horizontal Centration will be measured on a five point scale -2 to +2 (-2 Extremely nasal, -1 Slightly nasal, 0 = Optimum, +1 Slightly temporal, +2 Extremely temporal)

  2. Lens Fit - Vertical centration [One week]

    Lens Fit - Vertical Centration will be measured on a five point scale of -2 to +2 (-2 Extremely inferior, -1 Slightly inferior, 0= Optimum, +1 Slightly Superior, +2 Extremely Superior)

  3. Corneal Coverage [One week]

    Corneal Coverage will be measured on a five point scale 0f -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

  4. Lens Movement [One week]

    Lens Movement will be measured on a five point scale of -2 to +2 (-2 Extremely inadequate, -1 Slightly inadequate, 0- Optimum, +1 Slightly excessive, +2 Extremely excessive)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. They are aged between 18 and 40 years and have 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 can attain at least 6/12 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cameron Optometry Edinburgh Edinburg United Kingdom EH3 6SW
2 Simon Falk Eyecare Oakwood Leeds United Kingdom LS8 2HU
3 Phipps Opticians Heckmondwike United Kingdom WF16 0EZ

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Philip Morgan, Eurolens Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05020990
Other Study ID Numbers:
  • C20-691 (EX-MKTG-121)
First Posted:
Aug 25, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022