Phase 1
N=32
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT03697876 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Adverse Events — 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-165 (Drug); Artelac (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
3; 5 | — |
| PRIMARY Ocular Comfort Index |
20.36; 15.37; 15.47; 10.99 | — |
| SECONDARY Visual Acuity (VA) |
19.33; 18.00; 19.33; 19.33; 20.00; 18.67 | — |
| SECONDARY Intraocular Pressure (IOP) |
14.13; 14.20; 13.73; 13.53; 13.83; 14.00 | — |
| SECONDARY Number of Participants With Post-instillation Symptomatology |
4; 8; 7; 6; 9; 8 | — |
| SECONDARY Tear Breakup Time (TBUT) |
12.67; 12.80; 13.53; 13.47; 13.47; 13.40 | — |
| SECONDARY Number of Participants With Epithelial Defects (ED; Graded According to Oxford Scale) |
15; 15; 0; 0; 15; 15 | — |
Summary
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.
Hypothesis: Ophthalmic gel PRO-165 presents a safety and tolerability profile similar to Artelac® Nightime Gel in ophthalmological and clinically healthy subjects.
Phase I clinical study, controlled, of parallel groups, double blind, randomized, exploratory Therapeutic indication of PRO-165: Eye lubricant
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Age between 18 to 45 years.
- Both genders.
- Blood tests (complete blood count, three element blood chemistry and liver function tests within normal parameters specified by the reference laboratory with a lower and upper margin of 10%)
- Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute)
- Visual capacity 20/30 or better, in both eyes.
- Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion Criteria
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Women who are pregnant or lactating.
- Women without a history of bilateral tubal obstruction, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Known diagnosis of liver disease
- Inability to attend or answer the evaluations made in each of the visits.
- Positive tobacco use (specified as cigarette consumption regardless of quantity and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Contact lens users.
Medical and therapeutic exclusion criteria.
- History of any chronic-degenerative disease.
- Inflammatory or infectious disease, active at the time of study entry.
- Injuries or traumatisms not resolved at the time of entry into the study.
Data sourced from ClinicalTrials.gov (NCT03697876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.