Comparing the after-use sensation and safety of long acting (LA) carteolol 2 % versus timolol LA 0.5 % in simple intra-ocular hypertension and glaucoma

ISRCTN	ISRCTN31673586
DOI	https://doi.org/10.1186/ISRCTN31673586
Secondary identifying numbers	#529

Submission date: 03/03/2010
Registration date: 25/03/2010
Last edited: 31/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Fréderic Chiambaretta
Scientific

CHU de Clermont Ferrand Service
dOpthalmologie
Hopital St. Jaques
3 place Henri Dunant, BP 69
Cermont Ferrand
63000
France

Study information

Study design	Investigator-masked parallel group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised, parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma
Study acronym	Carteolol
Study objectives	In this study the hypothesis will be tested that a 3-month treatment with Carteolol is superior to a 3-month treatment with Timolol in the subjective tolerance (ocular discomfort) upon instillation. Ocular hypertension or Primary Open Angle Glaucoma (POAG) (superiority design)
Ethics approval(s)	1. Belgium (Lead Centre): Ethics Committee of UZ Leuven (KUL) approved on the 10th of April 2008 (ref: ML 4750) 2. Czech Republic: Local ethics committee (Eticke Komise) approved on the 17th of January 2008 (refs: protocol UtCIV; approval no. 1743107S-MEK) 3. France: Local ethics committee (Comité de protection des personnes Sud Est 6) approved on the 2nd of November 2007 (ref: AU 714) 4. Poland: Local ethics committee (Komisja Bioethyczna) approved on the 6th of January 2007 (ref: KB-517/2007) 5. Portugal: National Ethics Committee for Clinical Investigation (CEIC) approved on the 19th of May 2008 (ref: 0804AU135)
Health condition(s) or problem(s) studied	Unilateral or bilateral ocular hypertension; Primary Open Angle Glaucoma (POAG)
Intervention	Written informed consent was obtained at baseline visit 1 (day 0). Eligibility was determined by reviewing medical history, recording of concomitant medication, external eye examination (signs of inflammation on eye lids, lid closure, lid motility, bulbar motility, conjunctival injection), and a check of inclusion and exclusion criteria. Eligible patients were randomised to receive either 1. Carteolol LA 2%: Daily, 1 drop at 8 AM in the eye(s) to be treated over 3 months 2. Timolol LA 0.5%: Daily, 1 drop at 8 AM in the eye(s) to be treated over 3 months Patients received the appropriate medication and diary card. Follow up visits were carried out on days 30 and 90 (± 3 days). Further medication and diary cards were distributed on day 30 only. Used and unused bottles and diary cards were collected at both visits. Patients were not followed up beyond the end of the intervention period.
Intervention type	Other
Primary outcome measure	Evaluation of the subjective tolerance upon instillation (rate of patients experiencing symptoms of discomfort), graded as very good, good, bad or very bad, measured at baseline, 1 and 3 months
Secondary outcome measures	1. Assessment of each of the symptoms of the Glaucoma Symptom Scale [15] (Yes/ No): burning/smarting/stinging, tearing, dryness, itching, soreness/tiredness, feeling of something in the eye, blurry/dim vision, hard to see in daylight, hard to see in dark places and halos around the light (for those who report a given symptom, a bothersome scale will be used: very, somewhat, a little, not at all) 2. Slit lamp examination (examination of conjunctiva, cornea, iris, lens, anterior chamber), performed at baseline, 1 and 3 months 3. Tear-film-break-up-time-test (BUT-test; sec), performed at baseline, 1 and 3 months 4. Fluorescein staining of the cornea, performed at baseline, 1 and 3 months 5. Van Bijsterveld test (Lissamine green), performed at baseline, 1 and 3 months 6. IOP measured at 12 PM (+/- 30mn), measured at baseline, 1 and 3 months 7. Assessment of Visual acuity and visual field, measured at baseline (if no visual field performed during the previous 3 months) and at 3 months 8. Fundoscopy, performed at baseline, 1 and 3 months 9. Adverse events, reported at 1 and 3 months 10. Compliance, reported at 1 and 3 months
Overall study start date	11/12/2007
Completion date	10/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	194
Key inclusion criteria	1. Adult patients, men or women 2. Suffering from unilateral or bilateral ocular hypertension or POAG 3. Intraocular Pressure (IOP) controlled with beta-blocker monotherapy (IOP < 21mmHg and visual field stable) 4. Written informed consent
Key exclusion criteria	1. Age < 18 years 2. IOP not controlled with beta-blocker monotherapy 3. Angle closure, congenital and secondary glaucoma 4. Any pathology contraindicating an IOP measurement 5. Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months 6. Previous intolerance to carteolol or timolol, or to any other ingredients of the tested products 7. Beta-blocker contraindications 8. Ocular corticosteroids 9. Contact lens wearers 10. Severe systemic or ocular disease 11. Hypotension 12. Drug, alcohol abuse 13. Involvement in the last 30 days in any other investigational drug study 14. Expected change in treatment of concomitant disease 15. Patients with a history of recurrent ocular herpes and/or recurrent uveitis 16. Change in ocular treatment within the last month 17. Patients treated with other topical ocular treatment within the last month 18. Pregnant or lactating women 19. Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy 20. Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study 21. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period 22. Patients with neurotic, psychiatric disorders or suicidal tendencies
Date of first enrolment	11/12/2007
Date of final enrolment	10/08/2009

Locations

Countries of recruitment

Belgium
Czech Republic
France
Poland
Portugal

Study participating centre

CHU de Clermont Ferrand Service

Cermont Ferrand
63000
France

Sponsor information

Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)
Industry

c/o Gabriele Brenger
Brunsbütteler Damm 165-173
Berlin
13581
Germany

"ROR"	https://ror.org/049ncrn81

Funders

Funder type

Industry

Bausch & Lomb GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan