Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
1 other identifier
interventional
59
1 country
1
Brief Summary
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2022
CompletedResults Posted
Study results publicly available
October 11, 2023
CompletedOctober 11, 2023
May 1, 2022
9 months
October 28, 2020
June 20, 2023
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Baseline with low contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
After 30 minutes of dispense (Low Contrast VA)
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Baseline with High contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
After 30 minutes of dispense (High Contrast VA)
Secondary Outcomes (12)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Limbal Redness
At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Entrance (Prior to wear of study lens)
- +7 more secondary outcomes
Study Arms (3)
Soft Toric Custom Made contact lenses
EXPERIMENTALSubjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Soft Spherical Contact Lenses
ACTIVE COMPARATORSubjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Spectacle Correction
ACTIVE COMPARATORSubjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Interventions
Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Eligibility Criteria
You may qualify if:
- Subjects will only be eligible for the study if:
- They are of legal age between 18 and 40 years.
- 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 are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
- They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- They can be fitted satisfactorily with both lens types.
- They own an acceptable pair of spectacles.
- They agree not to participate in other clinical research for the duration of this study.
You may not qualify if:
- Subjects will not be eligible to take part in the study if:
- 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 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 an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
- They have a history of severe allergic reaction or anaphylaxis.
- They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eurolens Research
Manchester, M13 9PL, United Kingdom
Related Publications (1)
Read M, Morgan P, Maldonado-Codina C, Orsborn G, Vega J, Navascues-Cornago M. Evaluating the visual benefits of toric soft contact lenses using a novel pupil-controlled vision testing system. Cont Lens Anterior Eye. 2026 Jan 23;49(2):102604. doi: 10.1016/j.clae.2025.102604. Online ahead of print.
PMID: 41579512DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jose A. Vega, OD, MSc, FAAO
- Organization
- Coopervision
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Read
Eurolens Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
September 28, 2021
Primary Completion
June 21, 2022
Study Completion
June 21, 2022
Last Updated
October 11, 2023
Results First Posted
October 11, 2023
Record last verified: 2022-05