Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
This study has been completed.
Sponsor:
Vistakon
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00583908
First received: December 21, 2007
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Astigmatism |
Device: senofilcon A Device: balafilcon A toric Device: lotrafilcon B toric Device: omafilcon A |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3 |
Resource links provided by NLM:
Further study details as provided by Vistakon:
Primary Outcome Measures:
- Lens Orientation During Head Tilt. [ Time Frame: after fit of each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation on the eye with the head tilted.
- Visual Acuity During Head Tilt [ Time Frame: after each of the four lens insertions ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Degree of Lens Rotation in Superior Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing up.
- Degree of Lens Rotation in Superior-temporal Gaze. [ Time Frame: After each of 4 lens insertions., ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing up and out(towards the temple).
- Degree of Lens Rotation in Superior-nasal Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing up and in(towards the nose).
- Degree of Lens Rotation in Temporal Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing out(towards the temple).
- Degree of Lens Rotation in Nasal Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing in(towards the nose).
- Degree of Lens Rotation Inferior-temporal Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing down and out.
- Degree of Lens Rotation in Inferior-nasal Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing down and in.
- Degree of Lens Rotation in Inferior Gaze. [ Time Frame: After each of the four lens insertions ] [ Designated as safety issue: No ]Degree of lens rotation while participant is gazing down.
| Enrollment: | 14 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583908
Locations
| United Kingdom | |
| Visioncare Research Ltd. | |
| Farnham, United Kingdom, GU9 7EN | |
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
Investigators
| Principal Investigator: | Graeme Young, BSc, MPhil | Visioncare Research Ltd. |
More Information
No publications provided
| Responsible Party: | Vistakon |
| ClinicalTrials.gov Identifier: | NCT00583908 History of Changes |
| Other Study ID Numbers: | CR-0710 pt 3, ETOR-507(under GNR-011) |
| Study First Received: | December 21, 2007 |
| Results First Received: | August 18, 2009 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Vistakon:
|
astigmatism orientation visual acuity contact lenses |
Additional relevant MeSH terms:
|
Astigmatism Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013