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NCT00689078 · ClinicalTrials.gov registry record · Phase 4
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
A Phase 4 study of Allergic Conjunctivitis, sponsored by ORA.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00689078: Completed Phase 4 study of Allergic Conjunctivitis, sponsored by ORA.
NCT00689078 is a Phase 4 study of Allergic Conjunctivitis that has completed, run by ORA. The registered enrollment target is 36 participants, below the 133-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00689078, a Phase 4 study of Allergic Conjunctivitis, has completed, sponsored by ORA.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.
Primary Outcome
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Prednisolone Acetate 1%
- DRUG Prednisolone Acetate 0.12%
- DRUG Loteprednol Etabonate 0.2%
Study Locations (1)
Massachusetts
- Ophthalmic Research Associates - Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-05 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00689078 record still lists
NCT00689078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00689078 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00689078 about?
NCT00689078 is a clinical study titled "Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model". To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Compar...
What is the current status of trial NCT00689078?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2008-05. Estimated completion is 2008-06.
What conditions does trial NCT00689078 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT00689078?
The interventions under investigation include: Placebo (DRUG), Prednisolone Acetate 1% (DRUG), Prednisolone Acetate 0.12% (DRUG), Loteprednol Etabonate 0.2% (DRUG).
Who is sponsoring clinical trial NCT00689078?
This trial is sponsored by ORA, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00689078 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00689078's enrollment target sits among peer trials
36 17th of 20 higher than 4 of 20 other Allergic Conjunctivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Conjunctivitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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