A 12-month, multicenter, randomized, double-masked, parallel-group comparison of timolol-LA once daily and timolol maleate ophthalmic solution twice daily in the treatment of adults with glaucoma or ocular hypertension

Clinical Therapeutics

Volumn 26, Issue 4, 2004, Pages 541-551

  Mundorf, Thomas K ^a   Ogawa, Takahiro ^b   Naka, Hiroaki ^b   Novack, Gary D ^c   Stephens Crockett, R ^d  

^a Private Practice   (United States)

^b SENJU PHARMACEUTICAL CO LTD   (Japan)

^c PHARMALOGIC DEVELOPMENT INC   (United States)

^d Des Anal of Trials Assoc Inc   (United States)

Author keywords

Controlled trial; Glaucoma; Intraocular pressure; Sorbate; Timolol

Indexed keywords

EYE DROPS; TIMOLOL; TIMOLOL MALEATE;

ADULT; AGED; ANEMIA; ARTHROPATHY; ARTICLE; ASTHENIA; BIOMICROSCOPY; BLEPHARITIS; BRONCHITIS; CATARACT; CLINICAL TRIAL; COMMON COLD; CONJUNCTIVAL ERYTHEMA; CONJUNCTIVITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORNEA INJURY; COUGHING; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRY EYE; ERYTHEMA; EYE BURNING; EYE DISCOMFORT; EYELID DISEASE; FATIGUE; FEMALE; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; HYPHEMA; INFECTION; INTRAOCULAR HYPERTENSION; INTRAOCULAR PRESSURE; LACRIMATION; LACRIMATION DISORDER; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NERVOUSNESS; OCULAR ALLERGY; OCULAR PRURITUS; OPEN ANGLE GLAUCOMA; PAIN; PRIVATE PRACTICE; PROSPECTIVE STUDY; PUNCTATE KERATITIS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RETINA DISEASE; RHINITIS; SENSORY DYSFUNCTION; SIDE EFFECT; STINGING SENSATION; SYMPTOMATOLOGY; TOOTH DISEASE; TREATMENT OUTCOME; UNITED STATES; VISUAL ACUITY; VISUAL DISORDER; VISUAL FIELD DEFECT; VISUAL IMPAIRMENT; VITREOUS DISEASE;

EID: 2342620110     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(04)90056-2     Document Type: Article

References (14)

1. Boger WP III, Steinert RF, Puliafito CA, Pavan-Langston D. Clinical trial comparing timolol ophthalmic solution to pilocarpine in open-angle glaucoma. Am J Ophthalmol. 1978;86:8-18.
2. Yalon M, Urinowsky E, Rothkoff L, et al. Frequency of timolol administration. Am J Ophthalmol. 1981;92:526-529.
3. Soll DB. Evaluation of timolol in chronic open-angle glaucoma: Once a day vs twice a day. Arch Ophthalmol. 1980;98:2178-2181.
4. Wandel T, Charap AD, Lewis RA, et al. Glaucoma treatment with once-daily levobunolol. Am J Ophthalmol. 1986;101:298-304.
5. Laurence J, Holder D, Vogel R, et al. A double-masked, placebo-controlled evaluation of timolol in a gel vehicle. J Glaucoma. 1993;2:177-182.
6. Shedden AH. Timolol maleate in gel-forming solution: A novel formulation of timolol maleate. Chibret Int J Ophthalmol. 1994;10:32-36.
7. Shedden A, Laurence J, Tipping R, for the Timoptic-XE 0.5% Study Group. Efficacy and tolerability of timolol maleate ophthalmic gel-forming solution versus timolol ophthalmic solution in adults with open-angle glaucoma or ocular hypertension: A six-month, double-masked, multicenter study. Clin Ther. 2001;23:440-450.
8. Rhee DJ. TIMOPTIC-XE®. In: Physicians' Desk Reference. 32nd ed. Montvale, NJ: Thomson PDR; 2004:277-281.
9. Higashiyama M, Inada K, Ohtori A, Kakuji T. Improvement of the ocular bioavailability of timolol by sorbic acid. Int J Pharmaceut. 2004;272:91-98.
10. Novack GD, Mundorf TK, Crockett RS, et al. A double-masked, active-controlled, randomized, crossover, comfort, ocular safety, and systemic bioavailability study in healthy volunteers. ARVO Abstracts; 2002. Abstract 4066.
11. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research. National Adverse Drug Reaction Directory: Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). 3rd ed. Rockville, Md: FDA, 1989.
12. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;14:657-680.
13. Novack GD, Leopold IH. The toxicity of topical ophthalmic beta-blockers. J Toxicol Cutan Ocul Toxicol. 1987;6:283-297.
14. Wax MB, Novack GD, Robin AL. Adrenergic agents. In: Albert DM, Jakobiec FA, Azar DT, Gragoudas ES, eds. Principles and Practice of Ophthalmology. Philadelphia, Pa: WB Saunders; 2000:267-300.