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

Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: senofilcon A; Device: balafilcon A toric; Device: lotrafilcon B toric; Device: omafilcon A

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Farnham, United Kingdom, GU9 7EN
    • Visioncare Research Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens
Active Comparator: 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	Device: senofilcon A; toric contact lens; Device: balafilcon A toric; toric contact lens; Device: lotrafilcon B toric; toric contact lens; Device: omafilcon A; toric contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Lens Rotation in Superior Gaze.	Degree of lens rotation while participant is gazing up.	After each of the four lens insertions
Degree of Lens Rotation in Superior-temporal Gaze.	Degree of lens rotation while participant is gazing up and out(towards the temple).	After each of 4 lens insertions.,
Degree of Lens Rotation in Superior-nasal Gaze.	Degree of lens rotation while participant is gazing up and in(towards the nose).	After each of the four lens insertions
Degree of Lens Rotation in Temporal Gaze.	Degree of lens rotation while participant is gazing out(towards the temple).	After each of the four lens insertions
Degree of Lens Rotation in Nasal Gaze.	Degree of lens rotation while participant is gazing in(towards the nose).	After each of the four lens insertions
Degree of Lens Rotation Inferior-temporal Gaze.	Degree of lens rotation while participant is gazing down and out.	After each of the four lens insertions
Degree of Lens Rotation in Inferior-nasal Gaze.	Degree of lens rotation while participant is gazing down and in.	After each of the four lens insertions
Degree of Lens Rotation in Inferior Gaze.	Degree of lens rotation while participant is gazing down.	After each of the four lens insertions

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.
• Investigators: Principal Investigator: Graeme Young, BSc, MPhil, Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 2, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: astigmatism; contact lenses; orientation; visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-0710 pt 3; ETOR-507(under GNR-011)