NCT00544713

Brief Summary

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 14, 2011

Completed
Last Updated

December 14, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

October 12, 2007

Results QC Date

June 29, 2009

Last Update Submit

November 9, 2011

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90

    Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).

    Day 90

Secondary Outcomes (11)

  • Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90

    Day 90

  • Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90

    Day 90

  • Best Corrected Visual Acuity (BCVA) Status at Day 90

    Day 90

  • Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90

    Baseline, Day 90

  • Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90

    Baseline, Day 90

  • +6 more secondary outcomes

Other Outcomes (1)

  • Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60

    Day 14, Day 60

Study Arms (2)

Carboxymethylcellulose and Glycerin based artificial tear

EXPERIMENTAL

Carboxymethylcellulose and Glycerin based artificial tear

Drug: Carboxymethylcellulose and Glycerin based artificial tear

Carboxymethylcellulose based artificial tear

ACTIVE COMPARATOR

Carboxymethylcellulose based artificial tear

Drug: Carboxymethylcellulose

Interventions

Carboxymethylcellulose and Glycerin based artificial tearDRUG

As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake

Carboxymethylcellulose and Glycerin based artificial tear
CarboxymethylcelluloseDRUG

As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake

Also known as: Refresh Plus®
Carboxymethylcellulose based artificial tear

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

You may not qualify if:

  • Dry eye signs and symptoms
  • Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
  • Pregnancy or planning pregnancy
  • Uncontrolled systemic disease
  • Use of systemic medications affecting dry eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Therapeutic Area Head
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
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 14, 2011

Results First Posted

December 14, 2011

Record last verified: 2011-11

Locations

US(1)