Trial Outcomes & Findings for Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers (NCT NCT01317030)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

25 participants

Primary outcome timeframe

7 days following lens insertion

Results posted on

2020-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Contact Lens Wear 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 Non-Contact Lens Wear: No intervention
Overall Study STARTED	12	13
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contact Lens Wear n=12 Participants 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 n=13 Participants Non-Contact Lens Wear: No intervention	Total n=25 Participants Total of all reporting groups
Age, Continuous	41 years n=5 Participants	41 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days following lens insertion

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

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.

Outcome measures

Outcome measures
Measure	Contact Lens Wear n=12 Participants 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 n=13 Participants Non-Contact Lens Wear: No intervention
Hyaluronan Levels	4.52 ng/mL Standard Error .232	4.07 ng/mL Standard Error .183

Adverse Events

Contact Lens Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Contact Lens Wear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Steffen, O.D., M.S.

Bausch & Lomb Incorporated

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place