cloprostenol and Drug-Related-Side-Effects-and-Adverse-Reactions

Topics: Amides; Bimatoprost; Cloprostenol; Drug-Related Side Effects and Adverse Reactions; Eyelashes; Humans; Hypotrichosis; Ophthalmic Solutions; Prostaglandins, Synthetic

Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes.. We sought to compare the safety and efficacy of once-daily bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins.. In this 5-month study, subjects were randomized to receive once-daily bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations.. A higher percentage of subjects treated with bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 (P < .0001). Subjects in the bimatoprost 0.03% group also had statistically significantly greater increases in eyelash length, thickness, and darkness (P < .0001) than those in the vehicle group. For adverse events, only conjunctival hyperemia occurred at a statistically significant higher incidence rate in the bimatoprost 0.03% versus the vehicle group (P = .03).. Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis.. Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile.

Topics: Administration, Topical; Adult; Aged; Amides; Bimatoprost; California; Cloprostenol; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Eyelashes; Female; Follow-Up Studies; Humans; Male; Middle Aged; Reference Values; Risk Assessment; Treatment Outcome; Young Adult

To compare the toxicological profile of a new formulation of travoprost 0.004% ophthalmic solution (travoprost PQ), containing the preservative polyquaternium-1(PQ, polyquad), with the commercially available formulation of benzalkonium chloride (BAK)-preserved travoprost 0.004% ophthalmic solution (travoprost BAK) and BAK-preserved latanoprost 0.005% ophthalmic solution (latanoprost BAK).. Human conjunctival epithelial cells were incubated with phosphate-buffered saline (PBS), BAK 0.015%, BAK 0.020%, PQ 0.001%, travoprost PQ preserved with PQ 0.001%, travoprost preserved with BAK 0.015%, or latanoprost preserved with BAK 0.020%. Six toxicological assays were used to assess: cell viability (neutral red, Alamar blue), apoptosis (YO-PRO-1, Hoechst 33342), and oxidative stress (H(2)DCF-DA, hydroethidine). Apoptosis and oxidative stress were each reported according to cell viability as observed with neutral red and Alamar blue for a total of 10 analyses per treatment depending on the cell viability test used to interpret apoptosis and oxidative stress responses.. There were no significant differences in toxicity between cells exposed to PBS and cells exposed to travoprost PQ (10/10 analyses) or PQ 0.001% (9/10 analyses). Ten out of 10 analyses revealed that travoprost PQ produced significantly less cytotoxicity than latanoprost BAK (p < 0.0001). Travoprost PQ produced significantly better cell viability and less apoptosis than travoprost BAK (6/6 analyses, p < 0.0001). Travoprost BAK was significantly less cytotoxic than latanoprost BAK in 7 of 10 analyses (p < 0.0001). All 10 of the analyses revealed that BAK 0.015%, BAK 0.020%, and latanoprost BAK produced significantly more cytotoxicity than PBS (p < 0.0001). Travoprost BAK was significantly less cytotoxic than its corresponding BAK 0.015% preservative solution in 9 of 10 analyses (p < 0.0001).. A panel of in vitro toxicity analyses supports the safety of travoprost PQ. Travoprost PQ may be better for ocular surface health than BAK-preserved formulations of latanoprost or travoprost but clinical studies are required to validate these comparisons.

Topics: Antihypertensive Agents; Apoptosis; Benzalkonium Compounds; Cell Survival; Cells, Cultured; Cloprostenol; Conjunctiva; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Epithelial Cells; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Oxidative Stress; Polymers; Preservatives, Pharmaceutical; Prostaglandins F, Synthetic; Travoprost

Topics: Amides; Aminosalicylic Acids; Anti-Ulcer Agents; Antipsychotic Agents; Bimatoprost; Cloprostenol; Cyclohexanes; Drug Approval; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Galantamine; Glaucoma; Gonadotropin-Releasing Hormone; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Lipids; Mesalamine; Nateglinide; Nootropic Agents; Phenylalanine; Phenylhydrazines; Piperazines; Thiazoles; Travoprost