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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00331916
Other study ID # C-04-38
Secondary ID
Status Completed
Phase Phase 3
First received May 30, 2006
Last updated September 25, 2009
Start date November 2005

Study information

Verified date September 2009
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 1 Month and older
Eligibility Inclusion Criteria:

- Signs & Symptoms of conjunctivitis

Exclusion Criteria:

- Under 1 mo. age

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
quinolone


Locations

Country Name City State
United States US Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical cure and microbiological success
Secondary Individual signs and symptoms of bacterial conjunctivitis at each visit
See also
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Completed NCT00972777 - Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis Phase 2/Phase 3
Completed NCT00759148 - Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT00798577 - Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment Phase 4
Completed NCT02432807 - Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis Phase 3
Completed NCT01573910 - An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients Phase 3
Terminated NCT01330355 - Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis Phase 3
Completed NCT00332293 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT03004924 - Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo Phase 3
Completed NCT02980523 - Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) Phase 2
Completed NCT01877694 - Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis Phase 2
Completed NCT01175590 - Safety of Besivanceā„¢ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Phase 3
Completed NCT00464438 - A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis Phase 4
Completed NCT00312338 - Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora Phase 4
Recruiting NCT03235141 - Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers Phase 1
Completed NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) Phase 3
Completed NCT00105469 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) Phase 3
Recruiting NCT06363292 - Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. Phase 1
Withdrawn NCT01238783 - Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis Phase 2
Terminated NCT01740388 - Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Phase 3