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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01238783
Other study ID # C-09-061
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 9, 2010
Last updated November 29, 2011
Start date January 2011

Study information

Verified date November 2011
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

- Male and female patients of any race

- 5 years of age and older at the time of the Day 1 visit

- with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion Criteria:

- Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days

- Presence of punctal plug or punctal occlusion

- Visual Acuity worse than 20/80

- Upper respiratory infection

Study Design

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


Intervention

Drug:
AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Topical ocular dosed 3 times per day for 3 days
AL-15469A 0.5%
Topical ocular dosed 3 times per day for 3 days
AL-6515 0.3%
Topical ocular dosed 3 times per day for 3 days
Vehicle
Topical ocular dosed 3 times per day for 3 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Sustained Clinical Cure rate Day 3 No
Primary End of therapy Clinical Cure rate Day 4 Yes
Secondary Sustained bulbar conjunctival injection Day 3 Yes
Secondary Microbiological Success Day 4 No
See also
  Status Clinical Trial Phase
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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 NCT00331916 - AL-15469A for the Treatment of Bacterial Conjunctivitis Phase 3
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
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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 NCT00105469 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) Phase 3
Completed NCT00105534 - Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) 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
Terminated NCT01740388 - Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Phase 3