Comparative clinical trial of Krytantek Ofteno® versus Combigan D® in patients with primary open-angle glaucoma

Completed

• Conditions: Primary open angle glaucoma; Eye Diseases; Glaucoma

• Registration Number: ISRCTN48477221
• Lead Sponsor: aboratorios Sophia S.A. de C.V. (Mexico)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Patients must have a clinical diagnosis of mild to moderate primary open-angle glaucoma (POAG) with or without pseudoexfoliation and pigmentary dispersion or ocular hypertension
2. Patients may be of both masculine or feminine genders and must be 18 years old or older
3. Patients with intraocular pressure between 21 - 30 mmHg

Exclusion Criteria

1. Patients with one blind eye
2. Patients with visual acuity of 20/40 or worst in any of both eyes without a justifying cause
3. Patients with active stage history of any concomitant ocular disease besides the required one
4. Patients taking any medication, whether topically or by any route of administration, that decisively interferes in the study's results, until 48 hours previous to the day 1 of the trial or until a time period in which residual effects could be present
5. Sulfa allergy patients
6. Patients with history of hypersensibility or any medical situation that contraindicates or makes the using of risky for any of the study articles or their compounds under any route of administration as well as any drug or formulation derived from them or related to them
7. Contact lenses users
8. Fertile-age women who are not using an adequate contraceptive method as well as pregnant or breast-feeding women
9. Patients with history of cataract surgery with or without IOL implant (Pseudoaphakia or aphakia) three months or less prior to day 1 of the trial
10. Patients enrolled in any medical trial out of the Laboratorios Sophia S.A. de C.V. sponsorship under the last 90 days prior to this trial
11. Legally disqualified or mentally disabled patients who cannot sign the informed consent to participate in this clinical trial
12. Patients who cannot comply with the medical appointments or with all the protocol requirements
13. Patients who refuse to participate in this clinical trial
14. Patients with optic disc excavation equal to 0.8 or more
15. Normal-tension glaucoma patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure, measured at days 0, 7, 15, 30, 60 and 90. In all days the measurement will be at 8:00 am.

Secondary Outcome Measures

Name	Time	Method
1. Visual fields, evaluation at at days 0 and 90<br>2. Ocular surface fluorescein staining, measured at at days 0 and 90