Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

NCT ID: NCT00583908

Last Updated: 2015-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Detailed Description

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Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A

One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

toric contact lens

balafilcon A toric

Intervention Type DEVICE

toric contact lens

lotrafilcon B toric

Intervention Type DEVICE

toric contact lens

omafilcon A

Intervention Type DEVICE

toric contact lens

Interventions

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senofilcon A

toric contact lens

Intervention Type DEVICE

balafilcon A toric

toric contact lens

Intervention Type DEVICE

lotrafilcon B toric

toric contact lens

Intervention Type DEVICE

omafilcon A

toric contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. be at least 18 and less than or equal to 50 years of age
2. be able and willing to adhere to the instructions set forth in the protocol.
3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
4. Sign the STATEMENT OF INFORMED CONSENT.
5. Have normal, healthy eyes

Exclusion Criteria

1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
2. Pre-existing ocular disease precluding contact lens fitting.
3. Insufficient lacrimal secretions
4. Aphakia, keratoconus or a highly irregular cornea
5. Previous eye surgery involving the anterior segment
6. Current pregnancy or lactation (to the best of the subject's knowledge).
7. Use of concurrent ocular medication
8. Active participation in another clinical study at any time during this study.-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visioncare Research Ltd.

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graeme Young, BSc, MPhil

Role: PRINCIPAL_INVESTIGATOR

Visioncare Research Ltd.

Locations

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Visioncare Research Ltd.

Farnham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ETOR-507(under GNR-011)

Identifier Type: -

Identifier Source: secondary_id

CR-0710 pt 3

Identifier Type: -

Identifier Source: org_study_id

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