Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00813982
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief Summary

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Lotrafilcon A Experimental Contact Lens; Device: Lotrafilcon A Commercial Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Lotrafilcon A Contact Lens Lotrafilcon A experimental contact lens randomly assigned to one eye	Device: Lotrafilcon A Experimental Contact Lens; Experimental spherical, silicone hydrogel soft contact lens
Active Comparator: Commercial Lotrafilcon A Contact Lens Lotrafilcon A commercial contact lens randomly assigned to one eye	Device: Lotrafilcon A Commercial Contact Lens; Commercially marketed spherical, silicone hydrogel soft contact lens

Outcome Measures

Primary Outcome Measures

1. Overall Vision [1 week]

   Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day

• On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• Requires concurrent ocular medication

• Eye injury or surgery within twelve weeks immediately prior to enrollment

• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions

• Any active corneal infection

• Any use of medications for which contact lens wear would be contraindicated

• History of corneal refractive surgery

• Wears toric contact lenses

• Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT00813982
• Other Study ID Numbers: P-335-C-009
• First Posted: Dec 23, 2008
• Last Update Posted: Jun 29, 2012
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	One participant was enrolled but not dispensed due to failing inclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Experimental Contact Lens / Commercial Contact Lens
Arm/Group Description	Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Period Title: Overall Study
STARTED	59
COMPLETED	59
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Experimental Contact Lens / Commercial Contact Lens
Arm/Group Description	Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
Overall Participants	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.7 (10.3)
Sex: Female, Male (Count of Participants)
Female	42 71.2%
Male	17 28.8%

Outcome Measures

1. Primary Outcome

Title	Overall Vision
Description	Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.

Arm/Group Title	Lotrafilcon A Commercial Contact Lens	Lotrafilcon A Experimental Contact Lens
Arm/Group Description	Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.	Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	8.7 (1.5)	8.7 (1.7)

Adverse Events

Time Frame	1 week
Arm/Group Title	Lotrafilcon A Commercial Contact Lens		Lotrafilcon A Experimental Contact Lens
Arm/Group Description	Commercial spherical silicone hydrogel contact lens		Experimental spherical silicone hydrogel contact lens
All Cause Mortality
	Lotrafilcon A Commercial Contact Lens		Lotrafilcon A Experimental Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon A Commercial Contact Lens		Lotrafilcon A Experimental Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon A Commercial Contact Lens		Lotrafilcon A Experimental Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any pre-clinical and/or clinical data or impressions from this trial.