Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01118338
• Collaborator: (none)
• Enrollment: 376
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 187.6

Study Details

Study Description

Brief Summary

The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Redesigned Purevision Contact Lens; Device: PureVision Contact Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 376 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Redesigned Purevision Contact Lens Redesigned Bausch & Lomb PureVision contact lens	Device: Redesigned Purevision Contact Lens; Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Active Comparator: PureVision Contact Lens Bausch & Lomb PureVision contact lens	Device: PureVision Contact Lens; Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

Outcome Measures

Primary Outcome Measures

1. Symptoms and Complaints [1 month]

   Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.

Secondary Outcome Measures

1. Visual Acuity [1 month]

   Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

2. Percentage of Eyes With > Grade 2 Slit Lamp Findings [1 month]

   Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be adapted wearers of one of the listed contact lenses

• Subjects must be myopic

• Subjects must use a lens care system on a regular basis.

Exclusion Criteria:

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.

• Subjects with any systemic disease affecting ocular health.

• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Subjects with an active ocular disease or are using any ocular medication.

• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Subjects who have had any corneal surgery (eg, refractive surgery).

• Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01118338
• Other Study ID Numbers: 648
• First Posted: May 6, 2010
• Last Update Posted: Oct 6, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Bausch & Lomb Incorporated: contact lens
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	There were 188 participants enrolled into each group, for a total of 376 participants enrolled. There were 185 participants in the redesigned group and 183 participants in the control group who were eligible and dispensed lenses.

Arm/Group Title	Redesigned Purevision Contact Lens	PureVision Contact Lens
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Period Title: Overall Study
STARTED	185	183
COMPLETED	182	174
NOT COMPLETED	3	9

Baseline Characteristics

Arm/Group Title	Redesigned Purevision Contact Lens	PureVision Contact Lens	Total
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Total of all reporting groups
Overall Participants	185	183	368
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.0	30.6	31.3
Sex: Female, Male (Count of Participants)
Female	136 73.5%	130 71%	266 72.3%
Male	49 26.5%	53 29%	102 27.7%

Outcome Measures

1. Primary Outcome

Title	Symptoms and Complaints
Description	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses. There were 368 dispensed eyes in the redesigned group and 360 dispensed eyes in the control group evaluable for the analysis population for the assessment of symptoms and complaints.

Arm/Group Title	Redesigned Purevision Contact Lens	PureVision Contact Lens
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Measure Participants	184	180
Measure eyes	368	360
Lens handling upon insertion	83.2 (17.7)	83.6 (17.7)
Comfort upon insertion	78.1 (21.7)	74.6 (21.7)
Burning/stinging upon insertion	84.6 (19.0)	83.2 (19.0)
Comfort throughout the day	75.1 (22.2)	73.0 (22.2)
End of day comfort	67.6 (24.8)	65.1 (24.9)
Lens awareness	76.4 (22.6)	72.1 (22.6)
Lens cleanliness	84.5 (16.5)	81.5 (16.5)
Irritation	76.6 (22.4)	73.4 (22.4)
Itching	85.7 (18.5)	85.2 (18.5)
Dryness	75.1 (23.8)	73.5 (23.9)
Redness	88.5 (17.6)	86.6 (17.6)
Vision	82.9 (19.7)	82.0 (19.7)
Lens handling upon removal	88.3 (15.5)	86.6 (15.5)
Overall impression	72.8 (24.7)	67.7 (24.7)

2. Secondary Outcome

Title	Visual Acuity
Description	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses.

Arm/Group Title	Redesigned Purevision Contact Lens	PureVision Contact Lens
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Measure Participants	185	183
Measure eyes	370	366
Mean (Standard Deviation) [logMAR]	-0.028 (0.068)	-0.021 (0.068)

3. Secondary Outcome

Title	Percentage of Eyes With > Grade 2 Slit Lamp Findings
Description	Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

There were 188 participants (376 eyes) enrolled into each group, for a total of 376 participants enrolled (752 eyes). There were 372 eyes in the redesigned group and 374 eyes in the control group assessed for slit lamp findings during the study.

Arm/Group Title	Redesigned Purevision Contact Lens	PureVision Contact Lens
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Measure Participants	186	187
Measure eyes	372	374
Count of Units [eyes]	5	5

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 376 eyes dispensed the test lens and 376 eyes dispensed the control lens, assessed for adverse events.
Arm/Group Title	Redesigned Purevision Contact Lens		PureVision Contact Lens
Arm/Group Description	Redesigned Bausch & Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.		Bausch & Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
All Cause Mortality
	Redesigned Purevision Contact Lens		PureVision Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Redesigned Purevision Contact Lens		PureVision Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/185 (0%)		0/183 (0%)
Other (Not Including Serious) Adverse Events
	Redesigned Purevision Contact Lens		PureVision Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/185 (0%)		0/183 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.