CompletedNCT04613882Updated Oct 11, 2023Results posted

Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses

An interventional study of Soft Toric Custom Made Contact lens and Soft Spherical Contact Lenses in Astigmatism, sponsored by CooperVision, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by CooperVision, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 59
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study 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.

Read the detailed description

This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

Conditions studied

Astigmatism

Browse trials for

Astigmatism 413

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 59 is close to the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

CooperVision, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 29 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 59 participants (actual)

Study arms

Experimental
Soft Toric Custom Made contact lenses
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Device: Soft Toric Custom Made Contact lens · Device: Soft Spherical Contact Lenses · Device: Spectacle Correction
Active comparator
Soft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Device: Soft Toric Custom Made Contact lens · Device: Soft Spherical Contact Lenses · Device: Spectacle Correction
Active comparator
Spectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Device: Soft Toric Custom Made Contact lens · Device: Soft Spherical Contact Lenses · Device: Spectacle Correction

Interventions

DeviceSoft Toric Custom Made Contact lens
Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
DeviceSoft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
DeviceSpectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.

What researchers measure

Primary outcomes

Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: Baseline with low contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: After 30 minutes of dispense (Low Contrast VA)
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: Baseline with High contrast VA
Visual Acuity
Visual acuity was assessed using logMAR for each intervention.
Time frame: After 30 minutes of dispense (High Contrast VA)

Secondary outcomes

Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Limbal Redness
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Time frame: Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Oedema
Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Time frame: At Exit (After 30 minutes in each of three interventions)

Results

Posted Oct 11, 2023

Participant flow

First Intervention

Participant flow — First Intervention
Milestone	Spherical Contact Lens, Spectacle, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacle	Spectacle, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens
Started	14	6	9	5	6	13
Completed	14	6	9	5	6	13
Not completed	0	0	0	0	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	Spherical Contact Lens, Spectacle, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacle	Spectacle, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens
Started	14	6	9	5	6	13
Completed	14	6	9	5	6	13
Not completed	0	0	0	0	0	0

Third Intervention

Participant flow — Third Intervention
Milestone	Spherical Contact Lens, Spectacle, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacle	Spectacle, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens
Started	14	6	9	5	6	13
Completed	14	6	9	5	6	13
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryVisual Acuity

Visual acuity was assessed using logMAR for each intervention.

Time frame:: Baseline with low contrast VA
Reported as:: Mean · logMAR

Visual Acuity
logMAR	Overall Participants
Visual Acuity	0.2 ± 0.09

PrimaryVisual Acuity

Visual acuity was assessed using logMAR for each intervention.

Time frame:: After 30 minutes of dispense (Low Contrast VA)
Reported as:: Mean · logMAR

Visual Acuity
logMAR	Soft Spherical Contact Lenses	Soft Toric Custom Made Contact Lenses	Spectacle Correction
Visual Acuity	0.28 ± 0.013	0.24 ± 0.09	0.21 ± 0.09

PrimaryVisual Acuity

Visual acuity was assessed using logMAR for each intervention.

Time frame:: Baseline with High contrast VA
Reported as:: Mean · logMAR

Visual Acuity
logMAR	Overall Participants
Visual Acuity	-0.07 ± 0.07

PrimaryVisual Acuity

Visual acuity was assessed using logMAR for each intervention.

Time frame:: After 30 minutes of dispense (High Contrast VA)
Reported as:: Mean · logMAR

Visual Acuity
logMAR	Soft Spherical Contact Lenses	Soft Toric Custom Made Contact Lenses	Spectacle Correction
Visual Acuity	-0.02 ± 0.11	-0.08 ± 0.07	-0.1 ± 0.06

SecondarySlit Lamp Biomicroscopy Findings - Conjunctival Redness

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Conjunctival Redness
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Conjunctival Redness	1.0 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Conjunctival Redness

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Conjunctival Redness
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Conjunctival Redness	1.0 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Limbal Redness

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Limbal Redness
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Limbal Redness	0.9 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Limbal Redness

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Limbal Redness
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Limbal Redness	0.9 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Corneal Staining

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Corneal Staining
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Corneal Staining	0.2 ± 0.5

SecondarySlit Lamp Biomicroscopy Findings - Corneal Staining

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Corneal Staining
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Corneal Staining	0.3 ± 0.5

SecondarySlit Lamp Biomicroscopy Findings - Conjunctival Staining

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Conjunctival Staining
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Conjunctival Staining	0.4 ± 0.4

SecondarySlit Lamp Biomicroscopy Findings - Conjunctival Staining

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Conjunctival Staining
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Conjunctival Staining	0.6 ± 0.5

SecondarySlit Lamp Biomicroscopy Findings - Papillary Conjunctivitis

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis	1.1 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Papillary Conjunctivitis

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis	1.1 ± 0.3

SecondarySlit Lamp Biomicroscopy Findings - Corneal Oedema

Time frame:: Entrance (Prior to wear of study lens)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Corneal Oedema
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Corneal Oedema	0.0 ± 0.0

SecondarySlit Lamp Biomicroscopy Findings - Corneal Oedema

Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.

Time frame:: At Exit (After 30 minutes in each of three interventions)
Reported as:: Mean · units on a scale

Slit Lamp Biomicroscopy Findings - Corneal Oedema
units on a scale	Overall Participants
Slit Lamp Biomicroscopy Findings - Corneal Oedema	0.0 ± 0.0

Adverse events

Collected over The data was collected in the time frame of 90 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Overall Study	0/57 (0%)	0/57 (0%)	4/57 (7%)

Most frequent other events

Most frequent other events
Event	Overall Study
Corneal ScarEye disorders	1/57
asymptomatic corneal infiltrate eventEye disorders	1/57
Twitching in the eyeEye disorders	1/57
MigraineGeneral disorders	1/57

Baseline characteristics

There are six reporting groups for each of the randomization sequences of three study interventions. Here, we are not considering participants as some of the participants had only one eye examined and some of the participants had two eye examined. Therefore, we take number of eyes into consideration for better understanding and accuracy.

Age, Continuous
Age, Continuous(years)	Spherical Contact Lens, Spectacles, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacles	Spectacles, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens	Total
Mean	26.1 ± 4.8	27.3 ± 5.6	25.9 ± 5.0	28.2 ± 7.7	25.4 ± 6.7	27.8 ± 6.3	26.5 ± 5.7

Sex: Female, Male
Sex: Female, Male(Eyes)	Spherical Contact Lens, Spectacles, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacles	Spectacles, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens	Total
Female	14	5	13	6	3	17	58
Male	9	4	2	0	6	5	26

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Spherical Contact Lens, Spectacles, Toric Contact Lens	Spherical Contact Lens, Toric Contact Lens, Spectacles	Spectacles, Spherical Contact Lens, Toric Contact Lens	Spectacles, Toric Contact Lens, Spherical Contact Lens	Toric Contact Lens, Spherical Contact Lens, Spectacles	Toric Contact Lens, Spectacles, Spherical Contact Lens	Total
Count of participants	—	—	—	—	—	—	0

Study locations

1 site

Eurolens Research
Manchester, M13 9PL, United Kingdom

References and documents

Study documents

Protocol and statistical analysis plan · Apr 24, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04613882
Lead sponsor: CooperVision, Inc.
Responsible party: Sponsor
First posted: Nov 3, 2020
Start date: Sep 28, 2021
Primary completion: Jun 21, 2022
Completion: Jun 21, 2022
Results posted: Oct 11, 2023
Last update: Oct 11, 2023

Study contacts

Michael Read

principal investigator · Eurolens Research

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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Discussion

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Other studies in this condition

Astigmatism→

Other studies from this sponsor

CooperVision, Inc.

Start the discussion

Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses

Study summary

Conditions studied

Browse trials for

In context

Astigmatism

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria