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

Horus Pharma

Status: Completed

Conditions: Dry Eye

Treatments: Device: Optive™ eye drops; Device: DM05 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03517748

15E1122

2016-A01843-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

the investigational device: DM05

Experimental group

Description:

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

Treatment:

Device: DM05 eye drops

The comparative device : Optive™

Active Comparator group

Description:

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

Treatment:

Device: Optive™ eye drops