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NCT00833495
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation
Phase 2 trial testing Prednisolone Acetate 0.12% (Pred Mild®) in Allergic Conjunctivitis in 155 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | Fovea Pharmaceuticals SA |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 155 |
| Start date | 1 January 2009 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prednisolone Acetate 0.12% (Pred Mild®) — full drug profile →
- FOV1101-00 — full drug profile →
- Prednisolone Acetate 1% (Pred Forte®) — full drug profile →
- Placebo
Conditions studied
- Allergic Conjunctivitis — all drugs for Allergic Conjunctivitis →
Sponsor
Fovea Pharmaceuticals SA — full company profile →
Who can join
18 and older, any sex, with Allergic Conjunctivitis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Ocular Allergic signs and symptoms Diary Scores
Time frame: Between V2 and V3
Sponsor's own description
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following: * FOV1101-00 concentration 1 and Pred Mild® * FOV1101-00 concentration 2 and Pred Mild® * Vehicle of FOV1101-00 and Pred Forte® * Vehicle of FOV1101-00 and Vehicle of FOV1101-00
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Topical cyclosporine for atopic keratoconjunctivitis.
González-López JJ, López-Alcalde J, Morcillo Laiz R, Fernández Buenaga R, et al · · 2012 · cited 9× · PMID 22972132 · DOI 10.1002/14651858.cd009078.pub2
Verify or expand the search:
- PubMed search for NCT00833495
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Allergic Conjunctivitis
Currently open trials in the same condition.
- NCT07309432 — Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy · Phase 3 · recruiting
- NCT06686472 — Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00833495 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fovea Pharmaceuticals SA
- Last refreshed: 8 March 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00833495.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing