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

NCT00583908 | Completed Results

• 2 other identifiers: CR-0710 pt 3ETOR-507(under GNR-011)
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Astigmatism

Keywords

astigmatism; orientation; visual acuity; contact lenses

Outcome Measures

Primary Outcomes (2)

• Lens Orientation During Head Tilt.

  Degree of lens rotation on the eye with the head tilted.

  after fit of each of the four lens insertions

• Visual Acuity During Head Tilt

  logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.

  after each of the four lens insertions

Secondary Outcomes (8)

• Degree of Lens Rotation in Superior Gaze.

  After each of the four lens insertions

• Degree of Lens Rotation in Superior-temporal Gaze.

  After each of 4 lens insertions.,

• Degree of Lens Rotation in Superior-nasal Gaze.

  After each of the four lens insertions

• Degree of Lens Rotation in Temporal Gaze.

  After each of the four lens insertions

• Degree of Lens Rotation in Nasal Gaze.

  After each of the four lens insertions

Study Arms (12)

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

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

ACTIVE COMPARATOR

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

Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

Interventions

senofilcon A DEVICE

toric contact lens

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A; Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B; Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A; Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A; Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A; Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A; Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A; Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B; Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A; Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A; Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A; Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

balafilcon A toric DEVICE

toric contact lens

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A; Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B; Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A; Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A; Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A; Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A; Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A; Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B; Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A; Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A; Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A; Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

lotrafilcon B toric DEVICE

toric contact lens

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A; Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B; Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A; Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A; Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A; Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A; Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A; Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B; Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A; Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A; Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A; Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

omafilcon A DEVICE

toric contact lens

Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A; Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B; Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A; Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A; Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A; Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A; Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A; Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B; Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A; Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A; Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A; Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (1)

Visioncare Research Ltd.

Farnham, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism; Orientation, Spatial

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Spatial Behavior; Behavior

Results Point of Contact

• Title: Kurt Moody, OD FAAO
• Organization: Vistakon

kmoody1@its.jnj.com

904-443-3088

Study Officials

• Graeme Young, BSc, MPhil

  Visioncare Research Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: December 21, 2007
• First Posted: January 2, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: September 28, 2009

Record last verified: 2015-05

Locations

GB (1)