Objective Evaluation of Ocular Surface Lubricants in Two Environments

NCT01375582 | Completed Early Phase 1 DMC

• 1 other identifier: 35809
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

Conditions

Dry Eye

Keywords

Dry Eye; tear film; lipid; tear volume; environmental chamber; thermal imaging

Outcome Measures

Primary Outcomes (1)

• Tear Film Properties

  The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes. A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.

  Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.

Study Arms (1)

Drop Administration

EXPERIMENTAL

Drug: B & L Soothe Lubricant Eye Drops; Drug: Liposic EDO; Drug: OcuFresh Eye Wash

Interventions

B & L Soothe Lubricant Eye Drops DRUG

Eye Drop

Drop Administration

Liposic EDO DRUG

Eye Drop

Drop Administration

OcuFresh Eye Wash DRUG

Saline drop

Drop Administration

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-75 years
• Good general health
• Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
• Currently using an OTC artificial tear for ocular comfort, at least occasionally.
• At least one positive dry eye symptom.

You may not qualify if:

• Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
• Recent past eye surgery.
• Female subjects may not be pregnant or lactating.
• Infectious diseases

Sponsors & Collaborators

• University of Rochester: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• James V Aquavella, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)