Health Condition 1: H111- Conjunctival degenerations and deposits
Conditions
Interventions
Intervention1: Dipyridamole eye drops 0.008%: Duration of Treatment: 2 Months
Control Intervention1: Placebo: Duration of Placebo Treatment: 1 Month
Sponsors
OD Ocular Discovery Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy Male & Female Volunteers, age >=18 years, diagnosed with symptomatic ocular conjunctival degenerative lesions (pterygium or pinguecula)2.Subjects with lesion redness >=1, (scale 0 to 4)3.Women of child bearing potential must use methods of contraception, deemed effective by the Investigator, during study-related treatment 4.Subjects able to understand and willing to provide written informed consent 5.Subjects able to read and understand the requirements of the study and willing and able to participate and comply with all trial requirements 6.Subjects who have not participated in any clinical trial of a drug by ocular or systemic administration within the previous four weeks 7.Subject must be available for and willing to attend all evaluation visits
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrolled systemic disease 2. History of ophthalmic topical or systemic cyclosporine or steroids in the past 30 days 3. History of systemic or topical drugs that are known to cause dry eye in the last 30 days 4. History of artificial tears / lubricating drops use >=4 times daily 5. Use of non-trial eye drops during the trial 6. History of contact lens use in the last 30 days 7. History of allergic reaction or sensitivity to study drugs and excipients in the formulation 8. History of dipyridamole use in the previous 2 months 9. Evidence of active ocular infection, herpes keratitis (in last 2 months), or current active external eye pathology other than pinguecula and/or pterygium that might affect the results of the study. (E.g. KCS secondary to the destruction of conjunctival goblet cells occurring with vitamin A deficiency; scarring; cicatricial pemphigoid; alkali burns; Stevens-Johnson syndrome; trachoma; or irradiation eyelid exposure). 10. Presence of corneal haziness other than haziness caused by current pterygium or from presence of stable scars 11. Any ocular surgery within previous 2 years 12. Presence of uncontrolled blood glucose levels at time of screening ( >11.1mmol/l or 200mg/dl 2 hours after eating, or >7mmol/l or 126mg/dl in fasted state) 13. IOP >25 mmHg 14A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study period 15Women that have a positive test result for pregnancy at the time of enrollment 16Participation in a clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of topical dipyridamole in subjects with symptomatic ocular surface conjunctival degenerative lesions i.e. pinguecula and pterygium.Timepoint: Visit1 Screening Day(-8), Visit 2 Baseline Day (0), Visit 3 Day 14 ±2 days, Visit 4 Day 28 ±2 days, Visit 5 Day 42 ±2 days, Visit 6 Day 56 ±2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of topical dipyridamole in reducing symptoms and improving comfort in subjects with symptomatic ocular surface conjunctival degenerative lesions i.e. pinguecula and pterygium.Timepoint: Visit1 Screening Day(-8), Visit 2 Baseline Day (0), Visit 3 Day 14 ±2 days, Visit 4 Day 28 ±2 days, Visit 5 Day 42 ±2 days, Visit 6 Day 56 ±2 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Gupta
PGIMER
Outcome results
None listed