N/A
N=53
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT04613882 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Visual Acuity — 0.2 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soft Toric Custom Made Contact lens (Device); Soft Spherical Contact Lenses (Device); Spectacle Correction (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.02; -0.08; -0.1 | — |
| PRIMARY Visual Acuity |
-0.02; -0.08; -0.1 | — |
| PRIMARY Visual Acuity |
-0.02; -0.08; -0.1 | — |
| PRIMARY Visual Acuity |
-0.02; -0.08; -0.1 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Conjunctival Redness |
1.0 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Conjunctival Redness |
1.0 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Limbal Redness |
0.9 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Limbal Redness |
0.9 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Corneal Staining |
0.3 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Corneal Staining |
0.3 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Conjunctival Staining |
0.6 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Conjunctival Staining |
0.6 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis |
1.1 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis |
1.1 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Corneal Oedema |
0.0 | — |
| SECONDARY Slit Lamp Biomicroscopy Findings - Corneal Oedema |
0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
-
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.
Exclusion Criteria
-
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.
Data sourced from ClinicalTrials.gov (NCT04613882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.