PMID- 18793581
OWN - NLM
STAT- MEDLINE
DCOM- 20081007
LR  - 20190608
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 46
IP  - 8
DP  - 2008 Aug
TI  - Tafluprost, a new potent prostanoid receptor agonist: a dose-response study on 
      pharmacodynamics and tolerability in healthy volunteers.
PG  - 400-6
AB  - OBJECTIVE: Prostaglandin receptor analogs lower intraocular pressure (IOP) and 
      are used for the treatment of glaucoma. This study aimed to compare the safety, 
      tolerability and pharmacodynamics of four doses of the new, selective-prostanoid 
      receptor agonist, tafluprost (AFP-168) in a Phase I placebo-controlled study. 
      METHODS: Healthy volunteers (n = 16) received sequentially ascending doses of 
      tafluprost (0.0001%, 0.0005%, 0.0025% and 0.005%) in one eye, and placebo in the 
      other. Each treatment period consisted of 2 days of treatment, with 5 days 
      between the treatment periods. Safety and tolerability assessments, as well as 
      IOP measurements, were performed at defined intervals. RESULTS: Tafluprost was 
      generally well tolerated and no volunteer discontinued due to adverse events 
      (AEs). The most common ocular AE was ocular hyperemia, which was 
      mild-to-moderate, and highly concentration-dependent. All doses of tafluprost 
      decreased IOP, with the maximum effect occurring 12 hours after treatment. The 
      decrease in IOP relative to placebo was significantly more effective with 
      tafluprost 0.0025% and 0.005%, compared with tafluprost 0.0001% (p pound 0.005). 
      CONCLUSION: Tafluprost was well tolerated and effective in lowering IOP. These 
      data support further testing of tafluprost 0.0025% and 0.005%.
FAU - Sutton, A
AU  - Sutton A
AD  - Guildford Clinical Pharmacology Ltd., The Technology Center, Guildford, Surrey, 
      UK. asutton@gcpl.co.uk
FAU - Gouws, P
AU  - Gouws P
FAU - Ropo, A
AU  - Ropo A
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Prostaglandins F)
RN  - 0 (Receptors, Prostaglandin)
RN  - 0 (prostaglandin F2alpha receptor)
RN  - 1O6WQ6T7G3 (tafluprost)
SB  - IM
MH  - Administration, Topical
MH  - Adult
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*pharmacology
MH  - Dose-Response Relationship, Drug
MH  - Glaucoma/drug therapy
MH  - Humans
MH  - Hyperemia/chemically induced
MH  - Intraocular Pressure/*drug effects
MH  - Male
MH  - Middle Aged
MH  - Prostaglandins F/administration & dosage/adverse effects/*pharmacology
MH  - Receptors, Prostaglandin/agonists
MH  - Time Factors
EDAT- 2008/09/17 09:00
MHDA- 2008/10/08 09:00
CRDT- 2008/09/17 09:00
PHST- 2008/09/17 09:00 [pubmed]
PHST- 2008/10/08 09:00 [medline]
PHST- 2008/09/17 09:00 [entrez]
AID - 10.5414/cpp46400 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2008 Aug;46(8):400-6. doi: 10.5414/cpp46400.