WHO ICTRP trial
A randomized, double-blind, monocentric phase IV clinical study on the ocular…
EUCTR2006-000991-34-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2006-000991-34-DE |
|---|---|
| Public title | A randomized, double-blind, monocentric phase IV clinical study on the ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. in comparison to a reference product containing Carbomer 0.2 % with repeated ocular applications over 12 months in 120 patients with keratoconjunctivitis sicca - ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. |
| Scientific title | A randomized, double-blind, monocentric phase IV clinical study on the ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. in comparison to a reference product containing Carbomer 0.2 % with repeated ocular applications over 12 months in 120 patients with… |
| Primary sponsor | Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Germany |
| Conditions | Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec |
| Interventions | Trade Name: Vitagel Pharmaceutical Form: Eye gel INN or Proposed INN: retinol palmitate CAS Number: 79-81-2 Concentration unit: IU/g international unit(s)/gram Concentration type: equal Concentration number: 1000 - Trade Name: Liposic… |
| Registration date | Jun 3, 2006 |
| Target size | 120 |
| Secondary IDs | DMP 81.1.05 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: