Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00758784
First received: September 19, 2008
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye Disease |
Drug: Refresh Tears |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
MedlinePlus related topics:
Eye Diseases
U.S. FDA Resources
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Ocular staining [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Refresh Tears
sterile ophthalmic solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects 18 years of age or older
Exclusion Criteria:
- No active ocular conditions of disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758784
Locations
| United States, California | |
| ISTA Pharmaceuticals, Inc. | |
| Irvine, California, United States, 92618 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00758784 History of Changes |
| Other Study ID Numbers: | CL-S&E-0417082-P |
| Study First Received: | September 19, 2008 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis |
Corneal Diseases Lacrimal Apparatus Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013