Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01317030
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Duration (Months): 1.9
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief Summary

to evaluate tears between habitual contact lens wearers and non contact lens wearers

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: Contact Lens Wear; Device: Contact Lens Wear; Other: Non-Contact Lens Wear

Detailed Description

The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers Using a Schirmer Strip for Tear Collection
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Contact Lens Wear Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution	Device: Contact Lens Wear; Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.; Device: Contact Lens Wear; Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.
Non-Contact Lens Wear	Other: Non-Contact Lens Wear; No intervention

Outcome Measures

Primary Outcome Measures

1. Hyaluronan Levels [7 days following lens insertion]

   Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Have no allergic conjunctivitis.

• Not be using any topical ocular medications.

Exclusion Criteria:

• Considered by the Investigator to not be a suitable candidate for participation

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01317030
• Other Study ID Numbers: ROC2-10-110
• First Posted: Mar 17, 2011
• Last Update Posted: Jan 9, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	Contact Lens Wear	Non-Contact Lens Wear
Arm/Group Description	Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.	Non-Contact Lens Wear: No intervention
Period Title: Overall Study
STARTED	12	13
COMPLETED	12	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Contact Lens Wear	Non-Contact Lens Wear	Total
Arm/Group Description	Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.	Non-Contact Lens Wear: No intervention	Total of all reporting groups
Overall Participants	12	13	25
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	41	41	41
Sex: Female, Male (Count of Participants)
Female	6 50%	6 46.2%	12 48%
Male	6 50%	7 53.8%	13 52%

Outcome Measures

1. Primary Outcome

Title	Hyaluronan Levels
Description	Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers.
Time Frame	7 days following lens insertion

Outcome Measure Data

Analysis Population Description

DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.

Arm/Group Title	Contact Lens Wear	Non-Contact Lens Wear
Arm/Group Description	Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.	Non-Contact Lens Wear: No intervention
Measure Participants	12	13
Mean (Standard Error) [ng/mL]	4.52 (.232)	4.07 (.183)

Adverse Events

Arm/Group Title	Contact Lens Wear		Non-Contact Lens Wear
Arm/Group Description	Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.		Non-Contact Lens Wear: No intervention
All Cause Mortality
	Contact Lens Wear		Non-Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Contact Lens Wear		Non-Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Contact Lens Wear		Non-Contact Lens Wear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.