Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
1 other identifier
interventional
27
1 country
1
Brief Summary
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedResults Posted
Study results publicly available
November 22, 2021
CompletedNovember 22, 2021
November 1, 2021
9 months
August 14, 2020
October 22, 2021
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Vision Stability While Doing Tasks on Mobile Phone
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
30 minutes
Vision Stability While Doing Tasks on Desktop
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
30 minutes
Vision Stability While Walking
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
30 minutes
Secondary Outcomes (2)
Lens Fit for Test Contact Lens
10 minutes
Lens Fit
30 minutes
Study Arms (2)
Test Contact lens
EXPERIMENTALSubjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Control Contact lens
ACTIVE COMPARATORSubjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Interventions
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
Eligibility Criteria
You may qualify if:
- They are aged 18-35 years and have 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 are an existing wearer of soft spherical contact lenses in both eyes.
- They have a spherical component of their spectacle refractive error between
- DS and -6.50DS in both eyes.
- They have a cylindrical component of their spectacle refractive error between
- DC and -1.25DC in both eyes.
- 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 the study.
You may not qualify 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 (including comfort drops) or ointment on a regular basis.
- 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 any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jose A. Vega, O.D, MSc., FAAO
- Organization
- CooperVision. Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Morgan, PhD.
University of Manchester
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
August 14, 2020
First Posted
September 2, 2020
Study Start
September 3, 2020
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
November 22, 2021
Results First Posted
November 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share