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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00893139
Other study ID # C-08-077
Secondary ID
Status Completed
Phase Phase 2
First received May 4, 2009
Last updated July 11, 2014
Start date June 2009
Est. completion date January 2010

Study information

Verified date July 2014
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 765
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- 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.

- Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AL-38583 ophthalmic solution 0.05%

AL-38583 ophthalmic solution 0.10%

AL-38583 vehicle
Inactive ingredients used as a placebo comparator

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in sodium fluorescein corneal staining score Baseline, up to Day 35 No
Secondary Mean change from baseline in phenol red thread length Baseline, up to Day 35 No
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