NCT00893139

Brief Summary

The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
765

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

May 4, 2009

Last Update Submit

July 11, 2014

Conditions

Dry Eye

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in sodium fluorescein corneal staining score

    Baseline, up to Day 35

Secondary Outcomes (1)

  • Mean change from baseline in phenol red thread length

    Baseline, up to Day 35

Study Arms (3)

AL-38583 0.05%

EXPERIMENTAL

AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days

Drug: AL-38583 ophthalmic solution 0.05%

AL-38583 0.10%

EXPERIMENTAL

AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days

Drug: AL-38583 ophthalmic solution 0.10%

AL-38583 vehicle

PLACEBO COMPARATOR

Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days

Drug: AL-38583 vehicle

Interventions

AL-38583 ophthalmic solution 0.05%DRUG
AL-38583 0.05%
AL-38583 ophthalmic solution 0.10%DRUG
AL-38583 0.10%
AL-38583 vehicleDRUG

Inactive ingredients used as a placebo comparator

AL-38583 vehicle

Eligibility Criteria

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

You may qualify if:

  • Composite corneal staining score of greater than 5 in one or both eyes.
  • Schirmer II score of greater than 4 mm.
  • OSDI score of greater than 23.

You may not qualify if:

  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ravaughn Williams, OD, MS

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 5, 2009

Study Start

June 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 15, 2014

Record last verified: 2014-07