Condition category
Eye Diseases
Date applied
03/03/2010
Date assigned
25/03/2010
Last edited
31/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fréderic Chiambaretta

ORCID ID

Contact details

CHU de Clermont Ferrand – Service
d’Opthalmologie
Hopital St. Jaques
3 place Henri Dunant
BP 69
Cermont Ferrand
63000
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

#529

Study information

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

Acronym

Carteolol

Study hypothesis

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

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)

Study design

Investigator-masked parallel group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

11/12/2007

Overall trial end date

10/08/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

194

Participant 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

Recruitment start date

11/12/2007

Recruitment end date

10/08/2009

Locations

Countries of recruitment

Belgium, Czech Republic, France, Poland, Portugal

Trial participating centre

CHU de Clermont Ferrand – Service
Cermont Ferrand
63000
France

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bausch & Lomb GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes