Clinical trial NCT02242032 (phase 1, status: completed)
Conditions: dry eye disease
ICD codes: H04.121, H04.122, H04.123, H04.129, H35.3111, H35.3112, H35.3121
Drugs: p-321 ophthalmic solution, p-321 ophthalmic solution placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Individuals of both genders and any race will be eligible for study participation if
             they:

               1. Provide written informed consent.

               2. Are 18 - 80 years of age.

               3. Corneal fluorescein staining score ≥2/15 on the NEI/Industry scale

               4. Conjunctival lissamine staining score of ≥ 2/18 on the NEI/Industry scale

               5. Schirmer <10mm/5min

               6. Are willing and able to follow instructions and can be present for the required
                  study visits for the duration of the study.

               7. Female patients of child bearing potential must have a negative urine pregnancy
                  test at Screening and agree to use a medically acceptable form of birth control.
                  Male subjects who are sexually active must be willing to use highly effective
                  contraception (i.e., less than 1% failure rate) during heterosexual intercourse
                  from Day 1 through completion of the study.

               8. Have a history of Dry Eye Disease in both eyes supported by a previous clinical
                  diagnosis or have a self-reported history of subjective complaints for at least 4
                  months prior to Screening, low tear volume, and ocular staining.

               9. Have documented history of topical lubricants at least daily or the desire to use
                  topical lubricants in the past 4 months.

              10. Have normal lid anatomy

        Exclusion Criteria:

          -  Individuals are not eligible for study participation if:

               1. Have anterior segment eye disease except primary dry eye.

               2. Patients with an identifiable or suspected secondary dry eye, i.e., a documented
                  or likely systemic, ocular, pharmacologic, post-traumatic, post-surgical, or
                  external cause for dry eye symptoms or ocular surface staining.

               3. Patients with current punctal plugs, punctal occlusion, or history of
                  nasolacrimal duct obstruction are excluded.

               4. Have a history of glaucoma or intraocular pressure (IOP) > 25 mmHg at the
                  Screening Visit (Visit 1) or a history of elevated IOP within the past year prior
                  to Visit 1

               5. Contact lenses wear in the previous 30 days or during the Treatment Phase of the
                  study.

               6. Use of lid scrubs (including baby shampoos)

               7. Known hypersensitivity to the study investigational medicinal product, or
                  formulation excipients, including amiloride or related drugs or allergies to the
                  components of the study drug.

               8. Any significant chronic illness that, in the opinion of the Principal
                  Investigator (PI), could interfere with the study parameters.

               9. Use of any investigational product or device within 30 days prior to the
                  Screening Visit or during the study.

              10. Those unable in the opinion of the PI to comply fully with the study requirements
                  or complete the study.