Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)

• Status: Completed
• Trial end date: 2017-06-18
• Target enrollment: 0
• Participant gender: All

Summary

Aim: To demonstrate the non-inferiority of the PRO-122 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus Krytantek Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.

Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 30 patients will be assigned to receive the ophthalmic solution: Krytantek Ofteno ® (timolol 0.5%%/brimonidine 0.2%/dorzolamide 2%) 1 drop B.I.D. during 30 days and the second sequence 30 patients will be assigned to receive the ophthalmic solution: PRO-122 1 drop B.I.D. during 30 days in the same period. Washout period: 20 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Brimonidine Tartrate; Dorzolamide; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

Criteria

Inclusion Criteria:

• 18 years of age or older

• male or female.

• obtained in the external consultation.

• With diagnosis primary of open-angle glaucoma and / or hypertension classified as mild, moderate or severe glaucomatous damage, users of Krytantek Ofteno® at least two months prior to inclusion and under control of the target IOP.

• informed consent.

Exclusion Criteria:

General Criteria

1. Subjects with topical or systemic medication that interferes decisively in the results of the study. (Such as topical immunomodulators, lacrimal point tamponade, corticosteroids, ocular hypotensives other than those listed above, artificial tears with preservative).

2. Subjects (female) with an active sex life who are not using a contraceptive method.

3. Female Subjects in pregnancy or breastfeeding.

4. Female subjects with positive urine pregnancy test.

5. Positive drug addiction (verbal interrogation).

6. Subjects who have participated in any clinical research study in the last 40 days.

7. Legally or mentally disabled subjects to give informed consent for their participation in this study.

8. Subjects who can not comply with the appointments or with all the requirements of the protocol.

Ophthalmologic criteria

1. Subject with only one eye with vision.

2. Subjects with visual capacity 20/200 or worse.

3. Subjects with a narrow-angle history without treatment, with or without total or partial closure of the angle in either eye.

4. Subjects with corneal abnormalities that prevent applanation tonometry.

5. Subjects with ocular surgery or ocular trauma 6 months prior to inclusion.

6. Any ocular laser surgery 3 months prior.

7. Any uncontrolled or progressive retinal disease.

8. Inflammatory diseases of any kind.

9. Contact lens wearers.

10. Subjects with a history of hypersensitivity to any of the ingredients of the research product or its analogues.