A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
NCT00134992 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2006-06-09
Summary
The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.
Conditions
- Healthy
Interventions
- DRUG
-
Prednisolone acetate
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Customer Information · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2004-08-31
Countries
- Germany
Study Locations
More Related Trials
-
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
NCT01534195 ·Status: COMPLETED ·Phase: PHASE4
-
Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
NCT01120132 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
NCT04030962 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers
NCT00135824 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
NCT03063489 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
NCT06538662 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
NCT00799552 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
NCT00689078 ·Status: COMPLETED ·Phase: PHASE4
-
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
NCT01733992 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Iota-Carrageenan Eye Drops (NCX-4240)
NCT03009799 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Six-Week Safety Study of an Investigational Ophthalmic Solution
NCT01698814 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
NCT05969236 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations
NCT03098953 ·Status: COMPLETED ·Phase: PHASE1
-
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye
NCT00560638 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
NCT06263998 ·Status: RECRUITING ·Phase: PHASE1
-
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
NCT01162954 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
NCT07068958 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye
NCT03019627 ·Status: COMPLETED ·Phase: PHASE2
-
Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection
NCT01721694 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
NCT04139122 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
NCT03198000 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
NCT04779606 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants
NCT05992922 ·Status: TERMINATED ·Phase: PHASE2
-
Study of ESBA105 Eye Drops in Healthy Subjects
NCT00671619 ·Status: COMPLETED ·Phase: PHASE1
-
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
NCT01543490 ·Status: COMPLETED ·Phase: PHASE3