Efficacy and Acceptability of Two Lubricant Eye Drops

NCT00756678 | Completed Phase 4 Results

• 1 other identifier: MA-OPT-08-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Mean Frequency of Eye Drop Use Over 1 Week

  Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.

  1 week

Secondary Outcomes (3)

• Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16

  Baseline, Day 16

• Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16

  Day 16

• Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16

  Day 16

Study Arms (2)

1

ACTIVE COMPARATOR

Carboxymethylcellulose and Glycerin

Drug: Lubricant Eye Drops (Optive™)

2

ACTIVE COMPARATOR

Polyethylene glycol 400

Drug: Lubricating Eye Drops (blink® Tears)

Interventions

Lubricant Eye Drops (Optive™) DRUG

1 drop in both eyes as needed for 7 days'

Also known as: Optive™

1

Lubricating Eye Drops (blink® Tears) DRUG

1 drop in both eyes as needed for 7 days

Also known as: blink® Tears

2

Eligibility Criteria

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

You may qualify if:

• Male or Female
• At least 18 years of age
• Current use of artificial tears

You may not qualify if:

• Any uncontrolled systemic disease
• Pregnancy or planning a pregnancy
• Contact lens wear

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Chevy Chase, Maryland, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 31, 2011
• Results First Posted: October 31, 2011

Record last verified: 2011-09

Locations

US (1)