Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness

NCT ID: NCT03517748

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-03-30

Brief Summary

This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.

Detailed Description

Evaluation of the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between D0 and D35.

• Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between products for the following parameters:

• Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
• Evolution of OSDI score (Ocular Surface Disease Index).
• Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
• Evolution of Schirmer test result in worse eye.
• Evolution of Tear film Break-Up Time (TBUT) in worse eye.
• Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
• Evaluation of treatment performance by the investigator and the patient.
• Evaluation of the average frequency of use during 84 days for DM05 and OptiveTM.

Selection visit: D-14 to D-7

Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day (Hydrabak®):

D0 : inclusion visit Follow-up visits: D35, D84

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the investigational device: DM05

DM05 eye drops, multidose sterile emulsion, will be administered in the DM05 Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days

Group Type: EXPERIMENTAL

DM05 eye drops

Intervention Type: DEVICE

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

The comparative device : Optive™

Optive™ eye drops, multidose sterile solution, will be administered in the Optive Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days

Group Type: ACTIVE_COMPARATOR

Optive™ eye drops

Intervention Type: DEVICE

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Interventions

DM05 eye drops

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Intervention Type: DEVICE

Optive™ eye drops

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sex: male or female.
• Age: more than 18 years.
• Subject with a dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
• Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 or 2 weeks before inclusion (at 3 drops per day).
• Diagnosis of moderate to severe ocular dryness defined by a score OSDI (Ocular Surface Disease Index) ≥18.
• Subject with at least one eye with:

• Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 (Oxford scale from 0 to 15)

AND one the following criteria:

• Schirmer test ≥ 3mm/5 min and ≤9mm/ 5 min OR
• Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.

• Subject, having given freely and expressly his/her informed consent.
• Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigator's appreciation.
• In France: subject being affiliated to a health social security system.
• Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.

Exclusion Criteria

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject deprived of freedom by administrative or legal decision.
• Subject in a social or sanitary establishment.
• Major subject who is under guardianship or who is not able to express his consent.
• Subject being in an exclusion period for a previous study.
• Subject suspected to be non-compliant according to the Investigator's judgment.
• Subject wearing contact lenses during the study.
• Far best corrected visual acuity < 1/10
• Subject with severe ocular dryness with one of these conditions:

• Eyelid or blinking malfunction
• Corneal disorders not related to dry eye syndrome
• Ocular metaplasia
• Filamentous keratitis
• Corneal neovascularization
• Subject with severe meibomian gland dysfunction (MGD)
• Within the last 3 months prior to the inclusion, history of ocular trauma, infection or inflammation not related to dry eye syndrome.
• Within the last 12 months, history of ocular allergy or ocular herpes.
• Refractive or cataract surgery within the last 6 months.
• Any laser other than refractive surgery within the last 3 months.
• Any troubles of the ocular surface not related to dry eye syndrome.
• Ocular hypertension or glaucoma needing an hypotonic treatment
• Subject having used artificial tears in the 6 hours preceding the inclusion visit.
• Use during the month preceding the inclusion or during the study of: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs.
• Any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Baudouin, Pr

Role: PRINCIPAL_INVESTIGATOR

Hopital d Ophtalmologie des Quinze-vingts

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-A01843-48

Identifier Type: OTHER

Identifier Source: secondary_id

15E1122

Identifier Type: -

Identifier Source: org_study_id