Bioequivalence of Eye Drops and Spray Administration of Vigamox
This study has been completed.
Sponsor:
Advanced Ophthalmic Pharma
Information provided by:
Advanced Ophthalmic Pharma
ClinicalTrials.gov Identifier:
NCT00666042
First received: April 22, 2008
Last updated: January 18, 2012
Last verified: August 2009
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Purpose
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.
| Condition | Intervention |
|---|---|
|
Cataract |
Drug: Vigamox - administration in spray form Drug: Vigamox eye drops |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form |
Resource links provided by NLM:
MedlinePlus related topics:
Cataract
Drug Information available for:
Tetrahydrozoline hydrochloride
Boric acid
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Advanced Ophthalmic Pharma:
Primary Outcome Measures:
- Bioequivalency between the 2 ways of administration [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | February 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Vigamox delivered as spray
|
Drug: Vigamox - administration in spray form
Vigamox will be administered in a spray form
|
|
Active Comparator: B
Patients will receive the commercially available Vigamox drops
|
Drug: Vigamox eye drops
Vigamox eye drops
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients scheduled for elective cataract surgery
Exclusion Criteria:
- Allergy to Vigamox
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Adi Michaeli/Principal Investigator, Tel Aviv Medical Center |
| ClinicalTrials.gov Identifier: | NCT00666042 History of Changes |
| Other Study ID Numbers: | Eye drops vs. spray, different administrations |
| Study First Received: | April 22, 2008 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases Tetrahydrozoline Moxifloxacin Norgestimate, ethinyl estradiol drug combination Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Infective Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013